Archive for the ‘Hormone Physician’ Category

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT), a pioneering genomic diagnostics company, announced that the Federal Joint Committee (G-BA) has approved its Prosigna Breast Cancer Gene Signature Assay. The G-BA decision to reimburse the Prosigna test will provide access to the test for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer.

The Prosigna Assay is a second-generation breast cancer test, meaning that it uses advanced genomic technology combined with clinical and pathologic features to inform next steps for patients with early-stage breast cancer. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with tumor size, lymph node involvement, and a tumor proliferation score to provide early-stage breast cancer patients and their physicians with a prognostic score indicating the probability of cancer recurrence during the next 10 years.

We are pleased with the G-BA decision, which will enable more breast cancer patients and their physicians in Germany to benefit from the genomic insights offered by our Prosigna test, said Bonnie Anderson, chairman and chief executive officer of Veracyte. Further, because Prosigna is performed by laboratories locally, this decision will enable German laboratories to deliver precision medicine solutions directly to their physician customers.

The Prosigna test is recommended in guidelines from the German Association of Gynecologic Oncology (AGO), as well as the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO) and the National Institute for Health and Care Excellence (NICE) in the United Kingdom.

Every year around 70,000 women in Germany develop early breast cancer. In many cases, a clear therapy recommendation for or against adjuvant chemotherapy is challenging based on the clinicopathological criteria alone. The Federal Joint Committee supports the use of biomarkers, now including Prosigna, to inform treatment decisions based upon the patients individual cancer recurrence risk.

About Prosigna

Prosigna is a prognostic Breast Cancer Gene Signature assay indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as a prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor- Positive (HR+), lymph node-negative, Stage I or II breast cancer or lymph node-positive (13 positive nodes, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.

In addition to the risk of recurrence (ROR) information, in Europe the assay provides the intrinsic subtypes of the tumor tissue within three groups low, intermediate and high. The tests performance is validated for use on the nCounter Analysis System in laboratories across Europe.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The companys growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The companys tests in thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is in development. With Veracytes exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. For more information, please visit http://www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to Veracytes Prosigna Breast Cancer Gene Signature Assay for use in predicting long-term risk of recurrence among breast cancer patients. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. Examples of forward-looking statements include, among others, statements regarding Veracytes belief that its Prosigna Breast Cancer Gene Signature Assay helps physicians accurately predict long-term risk of recurrence among breast cancer patients. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: Veracytes ability to achieve and maintain reimbursement coverage for its tests; the continued inclusion of its tests in recommendations of medical associations and agencies; the benefits of Veracytes tests and the applicability of clinical results to actual outcomes. Factors that may impact these forward-looking statements can be found in Item 1A Risk Factors in our Annual Report on Form 10-K filed with the SEC on February 25, 2020 and in our Quarterly Report on Form 10-Q filed with the SEC on November 2, 2020. A copy of these documents can be found at the Investors section of our website at http://www.veracyte.com. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, and the Veracyte logo are trademarks of Veracyte, Inc.

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Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany - Business Wire

There's a variety of bread out there to choose from, but two of the most common types are white bread and whole wheat bread. While they are both made from grains, there are key health differences between the two types of bread due to the way that they're made.

Here's what you need to know about the differences between white bread and whole wheat bread, as well as which one is healthier for you.

Whole wheat bread contains more nutrients, but white bread may be fortified with vitamins: Since 100% whole wheat bread has all three components of the grain, it typically has a higher nutritional value than white bread. This is because the bran and the germ have richer concentrations of vitamins and minerals than the endosperm.

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Plus, the germ contains:

For example, a major supermarket brand's white bread may have 120 calories, whereas their 100% whole wheat option may have around 100 calories. Specific calorie differences will vary based on brands.

Whole wheat bread has more fiber: Another nutritional difference between white bread and whole wheat bread is that whole wheat bread has more fiber. White bread usually contains about 1 gram or less of dietary fiber per serving, and 100% whole wheat contains around 3 or 4 grams of dietary fiber. Again, specific values will vary brand by brand.

White bread may be a better choice if you have digestive issues: "Eating 100% whole wheat bread is a healthier option for most people unless you are having a flare-up of a GI condition, such as Crohn's disease, ulcerative colitis, gastroparesis, and diverticulitis or are suffering from diarrhea, then you may need to follow a lower fiber diet and choose more refined grains," says Pence.

This is because some GI conditions are aggravated by high-fiber foods, causing further GI discomfort. For example, if you have diarrhea, having a lot of fiber in your diet may further increase the frequency of stools.

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Why 100% whole wheat bread is usually a healthier choice than white bread - Business Insider India

Modern life has brought numerous dangers, as the environment is significantly polluted, and toxins and dangerous substances may threaten our wellbeing. Our health is greatly affected by the food and drinks we consume.

Water is of critical importance, so we are all advised to drink at least two liters of filtered water during the day. Moreover, we should avoid greasy, sugary, and salty foods, and focus more on natural and organic fruits and vegetables.

However, most of you are not aware of the consequences of the use of plastic containers. Namely, the companies that produce foods and beverages are more concerned about their financial profit, than the production of healthy and safe products for their customers.

Therefore, it is of high importance to learn the meaning of the labels on the bottom of plastic bottles, as they indicate the extent to which they are harmful.

Plastic bottles are constantly around us, as we often buy water bottles when we go to work when we go for a walk, we buy water for our children in school, we get several of these water bottles when we go on a trip, and so on.

However, these bottles are significantly harmful to our health, and this is indicated by the triangle found onevery bottles bottom.

This plastic is a far better option than many others, as it is not likely to release chemicals into the water and it is usually used for making the plastic containers of certain food products.

This plastic type is also safe, and it is usually white or transparent. It is used in the production of containers of syrups and yogurt.

This plastic type releases cancer-causing mixes, as well as metals, antimony, and EPA synthetic substance, which intervenes with the hormone capacity.

PVC releases two dangerous elements, whose combination affects the hormonal capacity. It is the most commonly used plastic in the production of bottles.

This kind of plastic discharges STYRENE inside the water, which is a dangerous cancer-causing substance. It is often used in single-use coffee glasses and fast-food containers.

It discharges the concoction BPA and it is undoubtedly the most dangerous one. PC is commonly used in the production of sports bottles, nourishment stockpiling, as well as baby food containers.

To conclude, only the first two types of plastic, PP and HDPE, are not dangerous to your health, as they do not release harmful chemicals into the water.

On the other hand, the use of the other plastic types can seriously endanger your health, so in order to prevent their harmful consequences, it is advisable to use only glass water bottles.

On the other hand, the use of the other plastic typescan seriously endanger your health,so in order to prevent their harmful consequences, it is advisable to use only glass water bottles.

This is not intended to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health care professional.

Source: http://www.healthyfoodadvice.net

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Plastic The Sillent Killer Check What Is Written At The Bottom Of The Plastic Packaging - johnscreekpost.com

If you've taken an over-the-counter pain reliever before, you've likely had aspirin or ibuprofen. These are both very common nonsteroidal anti-inflammatory drugs, or NSAIDs, that are typically used to treat pain, inflammation, and fevers.

They are popular active ingredients in various brand name products such as Advil and Motrin (ibuprofen) or Bayer and Ecotrin (aspirin). However, just because they are over-the-counter, it doesn't mean that they come without risks or are safe for everyone to use.

Aspirin is made out of salicylic acid, and ibuprofen is made from propionic acid. The difference between the two acids is due to their chemical structures, particularly where the carbon and oxygen are located.

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"When we inhibit those prostaglandins, we inhibit that inflammatory cascade of reactions which is what is causing pain. So, we eliminate the inflammation, or, reduce inflammation, and with it goes the pain as well," says Medhat Mikhael, MD, pain management specialist and medical director of the non-operative program at the Spine Health Center at MemorialCare Orange Coast Medical Center in Fountain Valley, California.

Mikhael says for some chronic pain conditions, ibuprofen may be taken long term during flare-ups, as long as they "interrupt" the doses and take a week or two off from the medication. Ibuprofen is more suitable than aspirin for longer-term use in situations like this.

Overall, Mikhael says they can both be used to treat the same problems, including:

Your doctor may recommend that you take daily baby aspirin if you are at high risk for heart attack or stroke, like if you have very high blood pressure or have had a heart attack before.

As with most medications, aspirin and ibuprofen both run the risk of side effects, including serious ones. Some potential side effects include:

But unlike aspirin, ibuprofen may increase your risk of cardiovascular problems. This is why it's so important to use medications as directed and only short term, not long term, to avoid these serious side effects.

The following groups of people may want to avoid ibuprofen due to the increased risk of related side effects:

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Aspirin vs. ibuprofen: The key differences and which one you should take - Business Insider India

PRESS RELEASE:3 November 2020, 07:00 CET

Biocartis and GeneproDx To Collaborate on Fully Automated ThyroidPrint test on Idylla

Mechelen, Belgium, 3 November 2020 Biocartis Group NV (the Company or Biocartis), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces it has signed a license, development and commercialization agreement with GeneproDx, a molecular diagnostics company based in Santiago, Chile, for the development of GeneproDxs novel genomic test ThyroidPrint on Biocartis rapid and easy to use molecular diagnostics platform Idylla.

Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla ThyroidPrint test, whereas Biocartis will be responsible for the distribution of the ThyroidPrint on Idylla through its growing commercial infrastructure of Idylla instruments across the globe.

Thyroid nodules are very common and are often detected during routine medical exam or by patient self-assessment. Only some 10% of fine needle aspirate (FNA) biopsy procedures1 reveal the presence of malignant cells, while approximately 70% confirm a benign (non-cancerous) diagnosis. The remaining 20% are reported as indeterminate, meaning that no certain diagnosis can be provided to physician and patients2. Annually, over 1.2 million thyroid cytology evaluations are reported as indeterminate3. In patients with such result, diagnostic surgery of the thyroid gland is frequently recommended4. The risk of malignancy in these indeterminate cases is estimated to be between 15-35%, meaning that surgical intervention is unnecessary in up to 65-85% of these cases4.

ThyroidPrint is a qRT-PCR5 based mRNA-expression classifier6 test that helps to determine whether a thyroid nodule with an indeterminate cytology result is benign or malignant7. A benign test result8 allows physicians to recommend watchful waiting as an alternative to diagnostic surgery. This prevents exposing patients to surgical risks and permanent thyroid hormone supplementation. Moreover, it significantly reduces health costs associated with unnecessary surgery3.

GeneproDxs ThyroidPrint was initially clinically validated in a multicenter trial in Chile, after which it was launched in Latin America3 in September 2018. Furthermore, the test was clinically validated in a second independent multicenter, prospective trial in the US in December 2019, demonstrating that ThyroidPrint performs in the same manner in populations with different ethnicities and genetic backgrounds9. Currently, a new international validation study is ongoing, including an estimated 200 individuals with indeterminate cytology results10, in leading academic sites in Europe, the US and Latin-America.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: We are very pleased to enter into a new collaboration where a high value gene signature test is ported on Idylla. By developing an Idylla version of ThyroidPrint, GeneproDx and Biocartis may enable broad availability of this test to laboratories and hospitals around the world, to help address this high clinical unmet need in thyroid patients. For Biocartis, this also means further expansion of the oncology menu into thyroid cancer.

Hernn Gonzlez MD, PhD, Professor of Surgery at the Pontifical Catholic University of Chile and Founder of GeneproDx, reacted: As clinicians, an important challenge today is to determine whether a thyroid nodule is malignant and a patient really needs to undergo surgical resection of the thyroid gland. In our first real world clinical utility experience, ThyroidPrint revealed a meaningful impact on the physician decision by reducing diagnostic surgery by more than 70% in patients with indeterminate cytology11. We are excited to use the rapid and easy-to-use Idylla technology to develop a ThyroidPrint test that physicians can request to be performed in their local laboratories. As such, patients across the world can have the first of its kind, fast and easy-access diagnostic solution for indeterminate thyroid cytology results.

Development of the ThyroidPrint on Idylla will be initiated in Q4 2020.

--- END ---

More information: BiocartisRenate DegraveHead of Corporate Communications & Investor Relations Biocartise-mail rdegrave@biocartis.comtel +32 15 631 729 mobile +32 471 53 60 64

GeneproDxFrancisca Mena Head of Corporate Communications GeneproDxemail fmena@geneprodx.com tel +569 5608 654About Biocartis

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as tests for SARS-CoV-2 and sepsis. More information:www.biocartis.com. Follow us on Twitter: @Biocartis_.

About GeneproDx

GeneproDxs mission is to offer patients with indeterminate thyroid nodules the highest quality of precision medicine through ThyroidPrint. GeneproDxs vision is to be pioneers and leaders in the diagnosis of patients with indeterminate thyroid nodules in Latin America, through permanent innovation and the highest quality standards. GeneproDxs ThyroidPrint is the first molecular test for indeterminate thyroid nodules clinically validated in Latin America and the US. More info on http://www.thyroidprint.com.

Biocartis and Idylla are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statementsCertain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

1 In FNA biopsy procedures, approximately 350,000 of which are performed annually in the US alone (Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012;96(2):329-349. doi:10.1016/j.mcna.2012.02.002), cells are collected from the thyroid nodule for microscopic examination

2 Faquin WC, Bongiovanni M, Sadow PM 2011 Update in thyroid fine needle aspiration. Endocrine pathology 22:178183.

3 S. Vargas-Salas et al., Genetic testing for indeterminate thyroid cytology: review and meta-analysis, 2018, Endocrine-Related Cancer, https://erc.bioscientifica.com/

4 To determine the true nature of the nodule as standard practice. Haugen BRM, Alexander EK, Bible KC, Doherty G, Mandel SJ, Nikiforov YE, Pacini F, Randolph G, Sawka A, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward D, Tuttle RMM, Wartofsky L 2015 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid: official journal of the American Thyroid Association

5 Quantitative Reverse Transcription PCR. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: http://www.genome.gov, last consulted on 22 October 2020

6 Based on RTqPCR analysis, combined with an advanced machine learning algorithm

7 This means that the probability of the nodule being malignant drops from 25% to less than 5%, allowing follow-up to be recommended as an alternative to surgery. Info and source: https://thyroidprint.com/en/home-us/, last consulted on 22 October 2020

8 NPV (Negative Predictive Value) > 95%

9 M. Zafereo et al., A Thyroid Genetic Classifier Correctly predicts benign nodules with indeterminate cytology: two independent multicenter, prospective validation trials

10 Results are expected end of October 2021

11 Dominguez et al., ThyroidPrint: Preliminary Clinical Utility Experience. Archives of Endocrinol & Metab Vol 63, Suppl 02, pp 81 2019

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Press news Biocartis Group NV: Biocartis and GeneproDx To Collaborate on Fully Automated ThyroidPrint test on Idylla - GlobeNewswire

While were still learning about new research on cannabidiol (CBD), what we know so far is promising.

People take CBD for a bunch of different reasons. Some claim it helps with anxiety and chronic pain. Others find CBD helpful for dealing with nausea.

Below, we take a look at the research on CBD and nausea. We also include a list of our top CBD picks for nausea and some pointers on how to shop for this kind of CBD product.

A lot of the research on CBD and nausea focuses on its benefits for people with cancer. Nausea and vomiting are often a side effect of chemotherapy treatment.

Animal studies suggest that CBD might help quell nausea because it interacts with serotonin receptors. This hormone influences how you feel namely, your mood and general sense of well-being.

While CBD may play a part in reducing nausea, researchers conclude that tetrahydrocannabinol (THC), the main psychoactive component of cannabis, does more of the heavy lifting when it comes to helping with nausea and vomiting.

Human studies also show that a combination of CBD and THC may provide relief from nausea in people going through chemotherapy.

The American Cancer Society includes cannabinoids on its list of drugs for managing nausea and vomiting at home. It explains that theyre helpful in cases where regular anti-nausea and vomiting drugs dont work.

Chemotherapy can also affect your appetite, and cannabinoids can help with this, too.

Currently, there are two synthetic cannabis-derived drugs approved by the Food and Drug Administration (FDA) for chemotherapy-related nausea and vomiting. They are Nabilone and Dronabinol.

Because the research shows that THC is probably more effective at reducing nausea than CBD, full-spectrum CBD products are your best CBD option for quelling queasiness.

Full-spectrum CBD has all the beneficial, naturally occurring cannabinoids from the cannabis plant, including teeny tiny amounts of THC up to 0.3 percent in federally legal products.

When choosing a CBD product, youll want to select a form of CBD that appeals to you. If youre feeling nauseous, you wont want to take something that makes you want to gag.

For instance, if youre having trouble keeping food down, opt for a tincture or oil that you place under your tongue rather than a flavored gummy.

We chose these products based on criteria we think are good indicators of safety, quality, and transparency. Each product in this article:

As a part of our selection process, we also considered:

Price: $

Each bottle of this CBD oil includes a measured dropper, making dosing easy. It comes in two flavors, but the lemongrass ginger variety may be a bit more palatable than the natural flavor if youre dealing with nausea.

Papa & Barkley sources its hemp from Colorado, Oregon, and Vermont farms. The company offers customers a 30-day, money-back guarantee. You can access the COA directly from the product page.

Price: $$$

Each full dropper of Lion Xs CBD oil delivers 50 milligrams of CBD. Lion X uses organic hemp extract to make its products.

In addition to full-spectrum CBD, the oil is also naturally flavored with peppermint. You can take it directly by mouth or drop it into beverages.

To access the COA, check the product page. One thing to note is that the final product is only tested for potency and the cannabinoid profile.The crude CBD oil is tested for contaminants, but that COA is only available upon request. Since contaminants can be introduced during the manufacturing process, those that are immunocompromised may want to choose a product from another company that tests its final product.

Price: $$

Some people dont like the taste of oils. If you can keep food down and prefer to take a capsule, you might want to try these gel capsules from Lion X. Lion X recommends that you take one soft gel per day.

Like the oil, you can find the cannabinoid and potency COA on the product page. If you want to review the contaminant COA from the raw CBD oil, youll have to email the company. Since contaminants can be introduced during manufacturing, if youre immunocompromised its best to buy from a brand that does comprehensive testing on its final products.

Price: $

This refreshing peppermint-flavored spray is easy to administer. Each spray provides 2 milligrams of CBD. PureKana recommends taking three to four sprays at a time up to three times a day.

The CBD spray also contains liposomal vitamin D complex and is made with organic Kentucky-grown hemp. Research suggests that liposomal vitamin D may be better absorbed than other forms.

You can access the COA for this spray via the product page.

Price: $

We understand that you may not want to take a CBD product that contains THC even in trace amounts which is why we included this broad-spectrum, peppermint-flavored tincture on our list. You can take it under your tongue as you would any other tincture.

GoGreen Hemp uses organic hemp grown in Colorado and has a 14-day return policy. The COA is available on the product page.

There are so many CBD products out there that shopping for them is enough to give anyone a headache. Weed out the good from the bad by keeping these things in mind:

This depends a bit on the form of CBD youve chosen.

You can take tinctures and oils by mouth using a dropper. Just place them under your tongue and hold it there for a few seconds before swallowing. Swallow capsules whole as you would any other pill, or chew on gummies.

Most companies give you an idea of how much or how often to take their CBD product. If youre new to taking CBD, though, its best to start with the smallest dose.

Need more guidance on how much CBD to take? Check out our guide on dosage.

Research finds that most people will have no trouble when taking CBD, but there is a chance you may experience side effects, including:

Taking CBD alongside a high-fat meal may increase the risk of side effects, according to some research.

Before you take CBD for nausea, talk to your healthcare provider. CBD can interact with certain medications, so its a good idea to be open and honest with your physician.

Its also worth having a chat with your doctor if youre interested in trying CBD for nausea and vomiting due to chemotherapy. There may be other medications or strategies you can try first.

Theres some evidence that CBD might help with nausea, but the current research is limited. THC may be more helpful.

That said, some people use CBD to successfully manage nausea.

If youve tried other treatments, havent found relief for your nausea, and want to try CBD, opt for full-spectrum products made with organic U.S.-grown hemp that have been tested by a third-party lab.

Is CBD Legal? Hemp-derived CBD products (with less than 0.3 percent THC) are legal on the federal level, but are still illegal under some state laws. Marijuana-derived CBD products are illegal on the federal level, but are legal under some state laws. Check your states laws and those of anywhere you travel. Keep in mind that nonprescription CBD products are not FDA-approved, and may be inaccurately labeled.

Steph Coelho is a freelance writer with chronic migraine who has a particular interest in health and wellness. When shes not click-clacking away on her keyboard, shes probably nose-deep in a good book.

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CBD for Nausea: Research and Best Products - Healthline

In tough times, you can help yourself by boosting the brain chemicals associated with happiness.

In this new normal (aka life in a pandemic) a few simple rituals always make me happy: that first sip of coffee, cuddles with my puppy, reading before work, and getting some exercise. I don't think I've ever left a dance workout class in a bad mood. Now more than ever, I'm leaning into these small things that make a difference in my day.

While a cup of coffee won't change whether you feel truly fulfilled, in uncertain times, there's value in boosting your mood when you can.

There are four main hormones (a type of chemical your body makes) that trigger feelings of happiness, and each chemical is connected to specific events or rewards. Understanding these chemicals and how they work can help you figure out even small ways to feel better amid such a stressful time.

To explain exactly how these "happiness" chemicals work, I spoke to Loretta Breuning, founder of the Inner Mammal Institute and author of Habits of a Happy Brain.

Almost everything that makes you feel "happy" is linked to one of the four happiness hormones: dopamine, serotonin, endorphin and oxytocin. Here are some ways you can boost them.

The hormone dopamine is associated with motivation and reward. It's why you feel gumption when you set an exciting or important goal, and why it feels good to reach that goal. On the flip side, if you have low dopamine (which experts say can occur with depression), it can explain feelings of low motivation or loss of interest in something you used to enjoy.

Committing to a hobby or sport can boost your dopamine.

"Approaching a reward triggers dopamine. When a lion approaches a gazelle, her dopamine surges and the energy she needs for the hunt is released. Your ancestors released dopamine when they found a water hole," Breuning says. "The expectation of a reward triggers a good feeling in the mammal brain, and releases the energy you need to reach the reward."

How to boost it:

There are some not-so-healthy habits that increase dopamine -- like drinking caffeine, eating sugar or taking certain recreational drugs. But you can find ways to kick this hormone up without turning to potentially unhealthy or addictive substances.

"Embrace a new goal and take small steps toward it every day. Your brain will reward you with dopamine each time you take a step. The repetition will build a new dopamine pathway until it's big enough to compete with the dopamine habit that you're better off without," Breuning says.

You may already have goals set around your career, work or how much money you'd like to make. But don't forget personal goals. Committing to a rewarding hobby or sport can be just as gratifying as professional goals. Don't just set a few big goals that will take longer to complete -- also adopt shorter-term goals so you stay motivated.

"Set a short-run, long-run, and middle-term goal so you will always be approaching one when another is blocked. Focus on things you have control over and don't wait for others to set your goals for you," Breuning says.

Serotonin is a neurotransmitter that plays a role in mood, but it also helps regulate other functions in your body like digestion, sleep and bone health. When it comes to happiness and how you feel every day, serotonin is important for reducing depression and regulating anxiety.

How to boost it:

"Confidence triggers serotonin. Monkeys try to one-up each other because it stimulates their serotonin. People often do the same," Breuning says. You've probably never thought about confidence on a neurochemical level, but according to Breuning, if you don't prioritize confidence, your serotonin levels could take a hit.

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If you are trapped in a cycle of low self-esteem or have had others undermine your confidence, it can be hard to build it back up. It may sound strange, but don't ignore your need for respect and status.

"You can develop your belief in your own worth. If you focus on your losses you will depress your serotonin, even if you're a rock star or a CEO. You can build the habit of focusing on your wins. Your serotonin will suffer if you don't," Breuning says.

Besides focusing on what you've achieved in life, you can also build confidence in other ways. One way to do this is by working out or adopting a new exercise routine, which helps bolster your confidence when you stick to it over time. Something else you can try is finding ways to get out of your comfort zone each day. Every day that you challenge yourself to adapt to something new, even if it feels uncomfortable at first, you build more confidence.

Oxytocin is sometimes called the "love" hormone and is associated with how people bond and trust each other. Certain activities like kissing, hugging and having sex can trigger the release of oxytocin in the brain.

It explains why you feel happy when you pet or cuddle with your pets. It's important in childbirth since oxytocin helps the mother's uterus contract to deliver the baby, and oxytocin plays a role in breastfeeding too. It also helps parents bond with a baby after birth.

How to boost it:

You can boost oxytocin by being physically intimate with others. But besides the physical aspect, it's important to know that there's an emotional connection to how oxytocin is released.

Loretta Breuning, author of Habits of a Happy Brain

"Social trust is what triggers oxytocin. If you hug someone you don't trust, it doesn't feel good. Trust comes first. You can build social trust by taking small positive steps toward people," Breuning says.

You can reach out to a friend or contact you'd like to get to know better. Send someone a thank you note or a card just to tell them you're thinking about them. "Take a small step toward someone each day, and they may reciprocate months later, but if you keep doing it you will build trust networks," Breuning says.

Endorphins are notoriously linked with exercise -- it's the phenomenon that explains the runner's high or post-workout endorphin "rush." They function as "natural painkillers" that help minimize pain and maximize pleasure. This chemical experience can explain why a runner may be able to push through a race with an injury that they don't notice until it's over.

"In the state of nature, it helps an injured animal escape from a predator. It helped our ancestors run for help when injured. Endorphins evolved for survival, not for partying. If you were high on endorphins all the time, you would touch hot stoves and walk on broken legs," Breuning explains.

How to boost it:

Laughter is one way to boost endorphins naturally -- so is eating dark chocolate, watching your favorite drama on Netflix, working out and meditating.

Endorphins are released in response to pain, but that doesn't mean you should seek out ways to cause yourself harm (like by overexercising or pushing yourself beyond your limits) just to feel good.

"Inflicting harm on yourself to stimulate endorphins is a bad survival strategy. Fortunately, there are better ways: laughing and stretching. Both of these jiggle your innards in irregular ways, causing moderate wear and tear and moderate endorphin flow," she says.

Editors' note: This week, we're running a special report on the science of happiness and how to strive for it during difficult, complex times. Read more about what the research says about how to be happy,everyday ways people are perking themselves up during the pandemic, and how chasing happiness too single-mindedly could actually make you feel worse.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Link:
How to boost happiness hormones like serotonin and dopamine in everyday life - CNET

Whether you want to lose 10 pounds or 50, shedding extra weight is tough. If you've tried before and fell short of your goal, it can be hard to stay motivated.

But you don't necessarily need to lose a ton of weight to experience health benefits, says Mir Ali, MD, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center.

In fact, research shows losing as little as 5% of your body weight can improve your health in many ways. Here are 10 proven health benefits of weight loss and tips for how to lose weight safely.

Losing weight improves insulin sensitivity in people with type 2 diabetes, says Preeti Pusalkar, a certified clinical nutritionist with Hudson Medical Center, a primary care provider in New York City.

Excess body fat leads to an increase in adipose tissue, which causes inflammation and interferes with the function of insulin the hormone that helps regulate blood sugar levels.

Weight loss reduces adipose tissue, which allows the body to manage blood sugar more effectively. Plus, you don't have to lose that much weight to see results. Research has found that just a 5% reduction in body weight improved blood sugar levels in adults.

Losing weight can also improve heart health by reducing pressure on arteries, meaning the heart doesn't have to work as hard to pump blood through the body. The result is lower blood pressure and low-density lipoprotein (LDL) cholesterol levels the "bad" kind of cholesterol that can increase your risk of heart disease, Pusalkar says.

And it doesn't matter if you lose weight through diet and exercise or weight-loss surgery like metabolic surgery you'll reap benefits regardless, according to a large 2020 study.

Researchers examined the effects of weight loss surgery on obese patients who either had weight loss surgery or who lost weight through lifestyle changes. The risk of heart disease for the surgical group decreased after a 5% to 10% loss of body weight while the nonsurgical group saw a decrease after losing about 20% of body weight.

Excess weight can increase blood pressure, and therefore your risk of stroke. This is because high blood pressure puts a strain on your blood vessels, making them stiffer and more likely to cause blood to clot.

"Losing weight helps improve the efficiency of the heart due to less constricted blood vessels," Pusalkar says.

Overweight people are more likely to suffer from sleep apnea a disorder characterized by disrupted breathing while sleeping. Excess weight can increase fat deposits in your neck, which can obstruct your airways.

If you suffer from sleep apnea, losing weight likely won't entirely cure the condition. However, losing just 10% to 15% of your body weight can improve sleep quality and reduce the severity of sleep apnea in moderately obese patients, according to the National Sleep Foundation.

Losing weight alleviates pressure on knees and joints, which can improve mobility, Pusalkar says. A large 2012 study of obese adults with type 2 diabetes found as little as a 1% drop in weight cut mobility limitations, such as difficulty walking or climbing stairs, by more than 7%.

While there is no direct correlation between weight loss and self-esteem, some studies show that weight loss can improve mood and self-confidence.

A 2014 review examined 36 studies to determine the psychological benefits of weight loss. Researchers found consistent improvements in body image, self-worth, and general well-being among subjects who lost weight.

Excess weight can cause joints to become stressed, damaged, and inflamed but losing weight can help.

A 2018 study examined obese adults with arthritis pain in their knees. Researchers found that losing 10% to 20% of body weight resulted in less pain and improved joint function than losing just 5% of body weight, which did not show any significant joint pain benefits.

The reason likely has to do with how quickly joints wear down when under additional stress from excess weight. "As the smooth surface at the ends of bones, or cartilage, becomes damaged and worn, you feel pain and stiffness in the joint," Pulsalkar says.

Because weight loss can improve sleep, you might also feel more energized during the day, Pulsalkar says. Excess weight also means your body has to work harder to move. Therefore, shedding some pounds means you use less energy to move. It also improves respiratory function, which can also make you feel more energized.

While research on the correlation between excess weight and sex drive is still emerging, weight gain has been shown to increase sex hormone-binding globulin (SHBG) levels in your blood. This can lower free testosterone levels and decrease your libido, Pulsalkar says.

According to the American Cancer Society, excess body weight is thought to be the cause of about 11% of cancers in women and about 5% of cancers in men. Obesity increases your risk of developing several different cancers, including:

The exact link between excess weight and cancer is still unknown, but researchers believe inflammation due to visceral fat the fat surrounding vital organs is to blame. Losing weight could lower your risk of developing these cancers.

Some people may need to lose significantly more weight to experience some of these benefits, Ali says. But for the most part, losing as little as 5% of your body weight can lead to many health benefits, like improved heart health and decreased risk of diabetes. But, before starting any weight loss program, it's important to talk with your doctor about the right plan and goals for you.

Original post:
10 benefits of losing weight: How a 5-10% loss can improve your health - Insider - INSIDER

Trophoblast cell surface antigen 2 (Trop-2) is a glycoprotein that spans the epithelial membrane surface and plays a role in cell self-renewal, proliferation, and transformation.1,2 Encoded by the TACSTD2 gene, Trop-2 is a 35-kDa protein composed of a large extracellular domain, a single transmembrane domain, and a short intracellular tail that is the functionally dominant part of the protein.1-4

Under physiological conditions, Trop-2 plays an essential role in embryonic development, placental tissue formation, embryo implantation, stem cell proliferation, and organ development.2 A low basal expression level of Trop-2 is found on the surface of multiple normal epithelial tissues, including skin and oral mucosa.1,3 Trop-2 can promote tumor growth and its overexpression is common in many types of malignant epithelial tumors.1,2,4

Expression of Trop-2 is regulated by several pro-oncogenic transcription factors (eg, CREB1, nuclear factor [NF]B, and HOXA10) via positive feedback relationships.2 Trop-2 expression may be upregulated because of the inactivation of several transcription factors (eg, HNF4A, TP63/TP53L, ERG, HNF1A/TCF-1, and FOXP3).1,2 Overexpression of Trop-2 accelerates the cancer cell cycle and drives cancer growth. Knocking out the TACSTD2 gene disturbs the proliferation of tumor cells, further validating the role of Trop-2 in tumorigenesis.1

Trop-2 was first elucidated as a transducer of intracellular calcium signals; however, it is now known to function in a variety of cell signaling pathways associated with tumorigenesis (Figure 1).1,2,4 Expression of Trop-2, as a calcium signal transducer, causes calcium to be mobilized from internal stores. Increased intracellular calcium levels activate MAPK, which in turn increases levels of phosphorylated ERK1 and ERK2.2,4 ERK1 and ERK2 are important mediators of cell cycle progression, angiogenesis, cell proliferation, cell invasion, and metastasis.2,4 Intracellular calcium also activates the NF-B pathway, which is involved in stimulation of cell growth, and the RAF pathway, which is essential for the upregulation of FOXM1, one of the most commonly overexpressed genes in human solid tumors.2

In addition to stimulating calcium release and MAPK signaling, Trop-2 is involved in several other pro-oncogenic signaling pathways, leading to tumor cell growth and proliferation. Activation of cyclin E and D further promotes cell cycle progression.4Alteration of the Notch, Hedgehog, and Wnt pathways may discourage appropriate stem cell proliferation and differentiation.2,4 Trop-2 signaling also appears to be dependent on -catenin.5 Direct interaction between -catenin and the intracellular domain of Trop-2, through -catenin signaling, enhances stem celllike properties (eg, self-renewal and transformation) of cancer cells.5 Attenuation of IGF-1 receptor signaling by Trop-2 encourages cancer growth and malignancy, particularly in lung cancers.2

Trop-2 is inextricably linked to cancer progression and metastasis because of its role as a key regulator of the hallmarks of cancer, including cell growth, proliferation, migration, invasion, and survival.4 A variety of human epithelial cancer cells are characterized by Trop-2 overexpression, including breast, lung, urothelial, gastric, colorectal, pancreatic, prostatic, cervical, head and neck, and ovarian carcinomas.2,3 In an analysis of 702 tissue samples from patients with breast cancer, Trop-2 expression was detected via immunohistochemistry (IHC) across a wide range of breast cancer subtypes.6 Trop-2 expression is substantially higher in hormone receptorpositive/HER2-negative (HR+/HER2-) disease and triple-negative breast cancer (TNBC) compared with other breast cancer subtypes, including HER2-positive disease.7

Trop-2 overexpression is also common in nonsmall cell lung cancer (NSCLC).8 Using IHC on tissues collected from the tumors of 68 patients with NSCLC, Trop-2 expression was significantly higher in NSCLC tissues compared with matched healthy tissues (P < .05). Moreover, its overexpression was associated with worse tumor, node, metastasis stage (P = .012), lymph node metastasis (P = .038), and histologic grade (P = .013).9

Bladder cancer, the most common urothelial cancer, is also marked by elevated Trop-2 expression.10,11 In a study of 102 transitional cell bladder cancer samples, IHC staining for Trop-2 demonstrated increased Trop-2 expression compared with noncancerous samples, and this expression pattern was significantly associated with worsened tumor grade (P = .001), stage (P < .0 01), and bladder cancer recurrence (P = .0 3).11

Molecular markers that influence the biological progress of tumors often serve as important prognostic indicators. Overexpression of Trop-2 has been associated with more aggressive disease, poorer overall survival (OS), and worse disease-free survival in patients with solid tumors.4 A meta-analysis conducted in 2016 explored the association of Trop-2 expression and prognosis in patients with a variety of solid tumors (N = 2569). Results from the study showed that high Trop-2 expression negatively affected OS (hazard ratio, 1.896; 95% CI, 1.599-2.247; P < .001) and disease-free survival (pooled hazard ratio, 2.336; 95% CI, 1.596-3.419; P < .0 01).12

Specific to breast cancers, increased Trop-2 mRNA is a strong predictor of lymph node involvement, distant metastasis, and poor OS.13,14 Trop-2 is expressed across all breast cancer subtypes; however, overexpression appears more common in aggressive disease subtypes, including HR+/HER2- disease and TNBC.7

Trop-2 overexpression is also associated with poor outcomes in patients with urothelial cancer. In an analysis of 102 tissue samples collected from patients with noninvasive bladder cancer, Trop-2 expression was higher in samples from patients who experienced disease recurrence compared with those who did not have recurrent disease (P = .0 3). Additionally, patients with Trop-2 overexpression had significantly lower rates of recurrence-free survival (P = .0 01).11 In a separate study, high Trop-2 expression analyzed by IHC was strongly correlated with bladder cancer severity and worsened disease prognosis, with particularly strong Trop-2 expression in muscle-invasive bladder cancer tissues compared with normal bladder tissues (P < .0 01).15

Taken together, the data indicate that Trop-2 is a potentially valuable therapeutic target, given the connection between its overexpression and poor prognosis in various solid tumors.4,15 Its value as a prognostic indicator and potential target for therapeutic development is particularly evident in advanced cancers that have limited or few treatment options available, such as TNBC and metastatic urothelial cancers.

Metastatic TNBC

TNBC is an aggressive form of invasive breast cancer that accounts for 15% to 20% of all breast cancers and a disproportionate number of deaths due to breast cancer.16-18 Its prevalence is particularly high in premenopausal women and those of African American and Hispanic descents.17,19 TNBC is characterized by a lack of estrogen and progesterone receptors and a low expression of HER2; therefore, TNBC cannot be effectively treated with standard hormone-based therapies and HER2-targeted agents.16, 20Although chemotherapy has shown promising results in early TNBC, the majority of patients relapse and progress to metastatic TNBC within the first 3 to 5 years after initial treatment.18 The treatment of metastatic TNBC remains a clinical challenge, as no standard-of-care chemotherapy exists for previously treated patients.17,18 There is an urgent unmet need for effective treatment options in patients with metastatic TNBC.18

Metastatic Urothelial Cancer

In the United States, an estimated 81,400 new cases of urothelial cancer will be diagnosed in 2020, and approximately 18,000 Americans will die from the disease.21 The majority of urothelial cancers arise in the bladder, and established risk factors for bladder cancer include older age, male gender, Caucasian race, family history, and smoking.22,23 Muscle-invasive and meta-static urothelial cancers represent 25% of urothelial carcinoma cases and are characterized by substantially worse prognostic outcomes.23,24 Current chemotherapeutic options for metastatic disease offer a modest median OS of 15 months and a 5-year survival of less than 5%.23,24 Long-term survival is infrequent, and newer treatment modalities that target distinct molecular biomarkers are warranted.24,25

As Trop-2 is a clinically relevant cell surface antigen among several solid tumor types, its overexpression on cancer cells makes it an ideal candidate for targeting by specific therapies.26 One targeted approach involves the use of antibody-drug conjugates (ADCs), a technology that has revolutionized the approach to cancer chemo-therapy over the past 2 decades.26

An ADC is designed to contain 3 components: a monoclonal antibody (mAb), a cytotoxic drug called a payload, and a linker that connects the mAb to the cytotoxin. The mAb binds specifically to its tumor-associated antigen (eg, Trop-2), thereby delivering the cytotoxin to the surface of the tumor cell. Once bound, the ADC is internalized through receptor-mediated endocytosis. Lysosomal degradation of the ADC ensues, facilitating the release of the cytotoxin and enabling it to bind to its intracellular target and induce apoptotic cell death (Figure 2).26,27 The targeted nature of ADCs allows potent therapy to be delivered to the cancer cell itself, limiting systemic exposure. The result is fewer adverse effects (AEs), a wider therapeutic window, and reduced exposure of the drug to efflux mechanisms that can increase drug resistance.26,27

Sacituzumab govitecan-hziy is the only FDA-approved Trop-2targeted ADC, and several other agents are under preclinical and clinical development.28

Sacituzumab govitecan-hziy is an ADC that binds to Trop-2 and delivers a potent cytotoxic drug into tumor cells.29,30 The FDA recently granted it accelerated approval for the treatment of metastatic TNBC, and it has also received fast track designation for metastatic urothelial carcinoma, NSCLC, and small cell lung cancer.28,30-32

The composition of sacituzumab govitecan-hziy has been optimized to effectively target tumors expressing Trop-2. A humanized monoclonal antibody (hRS7) binds to Trop-2 and delivers govitecan (SN-38) to the cell surface. SN-38 is the active metabolite of irinotecan and functions as a DNA topoisomerase I inhibitor. A hydrolysable CL2a linker covalently binds SN-38 to h R S 7.30 When released intracellularly, SN-38 causes double-stranded DNA breaks that lead to apoptosis.29 Additionally, the hydrolysable linker allows a portion of the SN-38 payload to be released into the tumor microenvironment, leading adjacent tumor cells to be killed via a bystander effect.31,32

Sacituzumab govitecan-hziy delivers SN-38 in its most active nonglucuronidated form. Because of its moderate toxicity profile, SN-38 is conjugated to hRS7 at a high drug-to-antibody ratio of up to 8 SN-38 molecules per antibody, allowing for greater drug delivery than systemic irinotecan can achieve.29,32 Irinotecan causes grade 3 to 4 diarrhea in approximately one-third of patients, whereas the lower toxicity of SN-38 may confer an improved therapeutic index.29,30 This high level of drug delivery may overcome the ability of Trop-2expressing tumors to repair DNA breaks.30

On April 22, 2020, sacituzumab govitecan-hziy received accelerated approval from the FDA for the treatment of adult patients with metastatic TNBC who have received at least 2 prior therapies for metastatic disease.28 Approval was based on findings of the phase 1/2, single-arm, multicenter IM-T-IMMU-132-01 trial (NCT01631552), in which sacituzumab govitecan-hziy produced durable responses in a subset of patients with heavily pretreated metastatic TNBC.31,33

The IM-T-IMMU-132-01 trial enrolled 108 patients with metastatic TNBC who had received at least 2 prior treatments for metastatic disease. In the study population, the median number of prior systemic therapies in the metastatic setting was 3, and the majority of patients received prior taxanes (98%) and anthracyclines (86%) in the neoadjuvant or metastatic setting. The median age of study patients was 55 years (range 31-80); 99% were female, and 76% were Caucasian.31Brain metastases were present in 23% of patients, and visceral metastases were present in 77% of patients; these included metastases in the lung/pleura (57%), the liver (42%), and other visceral organs (adrenal glands, pancreas, and kidney; 7%).31

Patients received sacituzumab govitecan-hziy 10 mg/kg administered intravenously on days 1 and 8 of 21-day cycles. Treatment continued until disease progression or unacceptable toxicity. The primary efficacy end point was objective response rate (ORR) assessed according to RECIST 1.1 tumor criteria. The secondary efficacy end points included time to response, duration of response, clinical benefit rate (defined as a complete or partial response or stable disease for 6 months), progression-free survival (PFS), and OS.31

After a median follow-up duration of 9.7 months, an objective response occurred in 36 of 108 patients (ORR, 33.3%; 95% CI, 24.6%-43.1%), including a complete response in 3 patients.31 The median time to response was 2 months (range 1.6-13.5). The median response duration was 7.7 months (95% CI, 4.9-10.8), with 55.6% of patients responding at 6 months and 16.7% of patients still responding at 12 months.31,34 An independent central review of the data found a similar ORR and median response duration (34.3% and 9.1 months, respectively).31 The clinical benefit rate, including stable disease for at least 6 months, was 45.4%. Median PFS was 5.5 months; the estimated probability of PFS at 6 and 12 months was 41.9% and 15.1%, respectively. Median OS was 13 months (95% CI, 11.2-13.7); the estimated probability of survival at 6 and 12 months was 78.5% and 51.3%, respectively.31

The most common AEs of any grade were nausea (67%), neutropenia (64%), diarrhea (62%, predominantly grade 1), and fatigue (55%). Of grade 3 or 4 AEs, the most common were neutropenia, decreased white cell count, and anemia (occurring in 42%, 11%, and 11% of patients, respectively).31 Serious AEs occurred in 32% of patients, with the most common being febrile neutropenia (7%), vomiting (6%), nausea (4%), diarrhea (3%), and dyspnea (3%). Occurrence of AEs led to treatment interruption in 44% of patients, dose reductions in 34%, and discontinuation of treatment in 3%.31,34

IM-T-IMMU-132-01 Trial HR+/HER2- Subpopulation Analysis

Treatment with sacituzumab govitecan-hziy showed encouraging results in a prespecified subpopulation of patients with histologically confirmed HR+/HER2- metastatic breast cancer from the IM-T-IMMU-132-01 trial.32

A total of 54 patients with histologically confirmed HR+/HER2- metastatic breast cancer were enrolled. Eligible patients had received at least 1 line of hormone-based therapy and at least 1 prior chemotherapy in the metastatic setting. The median age of enrollees was 54 years (range, 33-79); aside from required prior hormone-based therapy, previous chemotherapies included a taxane (85%), an anthracycline (67%), capecitabine (65%), a CDK4/6 inhibitor (61%), an mTOR inhibitor (44%), and an immune checkpoint inhibitor (1.9%). After a washout period of at least 2 weeks since prior treatment, sacituzumab govitecan-hziy was dosed at 10 mg/kg via intravenous infusion on days 1 and 8 of 21-day cycles.32

The primary efficacy end point was ORR. Of the 54 patients enrolled, 17 patients achieved partial responses during a median follow-up duration of 11.5 months (ORR, 31.5%; 95% CI, 19.5%-45.6%). In the key secondary outcomes, patients experienced a median PFS of 5.5 months (95% CI, 3.6-7.6) and a median OS of 12.0 months (95% CI, 9.0-18.2). The median time to response was 2.1 months (95% CI, 1.4-7.8), and median duration of response was 8.7 months (95% CI, 3.7-12.7). Of the 17 responders, 4 achieved a response lasting more than 12 months (24%). The clinical benefit rate was 44.4% (95% CI, 30.9%-58.6%), with 7 patients showing stable disease for at least 6 months.32

Safety analyses showed a manageable AE profile for sacituzumab govitecan-hziy. There were no reports of cardiac toxicity or severe peripheral neuropathy. The most common grade 3 or higher treatment-related AE was neutropenia, which occurred in 50% of patients. The incidence of diarrhea was 46% and was mild overall. Grade 3 diarrhea was reported in 4 patients, with no reports of grade 4.32 Serious AEs occurred in 2 patients, who experienced febrile neutropenia and 1 case each of neutropenia, viral pneumonia, sepsis, diarrhea, nausea, vomiting, dehydration, and acute respiratory failure.32

ESMO 2020 Data: ASCENTTrial in Metastatic TNBC (NCT02574455)

Final results of the international, multicenter, open-label ASCENT trial (NCT02574455) were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. ASCENT was the first phase 3 study of an ADC to show improvement in PFS and OS compared with standard-of-care chemotherapy in patients with previously treated metastatic TNBC.35,36

A total of 529 patients with metastatic TNBC were randomized 1:1 to receive either sacituzumab govitecan-hziy or physicians choice of single-agent chemotherapy (capecitabine, eribulin, vinorelbine, or gemcitabine). The dose of sacituzumab govitecan-hziy was 10 mg/kg intravenously on days 1 and 8 of 21-day cycles. All patients had histologically or cytologically confirmed TNBC refractory to or relapsed after at least 2 prior chemotherapies including a taxane. The median age of the study population was 54 years, and the median number of prior chemotherapies received was 4.

In the primary end point, sacituzumab govitecan-hziy significantly improved median PFS (hazard ratio, 0.41; P< .0001) compared with chemotherapy. The sacituzumab govitecan-hziy treatment group achieved a median PFS of 5.6 months compared with 1.7 months in the chemotherapy treatment group. Compared with chemotherapy, sacituzumab govitecan-hziy treatment also significantly improved key secondary end points of OS (12.1 vs 6.7 months; hazard ratio, 0.48; P < .0001) and ORR (35% vs 5%; P < .0001).35,36

The most common treatment-related grade 3 or higher AEs with sacituzumab govitecan-hziy compared with chemotherapy were neutropenia (51% vs 33%, respectively), diarrhea (10.5% vs < 1.0%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%). No treatment-related deaths were reported, and no cases of neuropathy or interstitial lung disease greater than grade 3 occurred with sacituzumab govitecan-hziy.35

ESMO 2020 Data: Sacituzumab Govitecan-hziy in Combination with Talazoparib for Patients with Metastatic TNBC (NCT04039230)

At the ESMO Virtual Congress 2020, investigators presented the trial design, objectives, and status of a phase 1/2, open-label study that will investigate the efficacy and safety of sacituzumab govitecan-hziy in combination with the PARP inhibitor talazoparib for patients with metastatic TNBC.37 PARP is involved in repairing damaged DNA and is required for clearance of Trop-2 cleavage complexes; thus, PARP inhibitors may be complementary therapeutic partners with sacituzumab govitecan-hziy.37, 38

This study will include a dose escalation in phase 1b followed by a dose expansion in phase 2. Patients will receive sacituzumab govitecan-hziy on days 1 and 8 of 21-day cycles and talazoparib daily on days 15 to 21 of each cycle.38 The primary objective of phase 1b is to assess the dose-limiting toxicity rate and maximum tolerated dose of sacituzumab govitecan-hziy when given in combination with talazoparib. From these data, investigators will determine the recommended phase 2 dose. During phase 2, investigators will assess the ORR, PFS, OS, and clinical benefit rate. As of August 30, 2020, the trial was undergoing active recruitment, and a total of 20 patients were enrolled.37, 38

ESMO 2020 Data: Sacituzumab Govitecan-hziy for Breast Cancer Brain Metastases (NCT03995706)

SN-38, the cytotoxic payload delivered by sacituzumab govitecan-hziy, crosses the blood-brain barrier and is often included in central nervous system (CNS) cancer regimens.39 Investigators hypothesized that sacituzumab govitecan-hziy would yield therapeutically relevant SN-38 concentrations within the CNS of patients under-going craniotomy for breast cancer brain metastases or recurrent glioblastoma.39,40

In this single-center, nonrandomized, phase 0 study (NCT03995706), patients receive a single 10-mg/kg intravenous dose of sacituzumab govitecan-hziy the day prior to craniotomy and then resume therapy (on days 1 and 8 of 21-day cycles) after recovery. To date, 14 patients have been treated. For patients with recurrent glioblastoma (n = 7), the mean SN-38 concentration was 420 nM; for patients with breast cancer brain metastases (n = 7), the mean SN-38 concentration was 626 nM. Among those patients with residual measurable disease, 2 partial intracranial responses have been observed in each group after 12 weeks of treatment (ORR, 28% and 50% for glioblastoma and breast cancer brain metastases, respectively). As of September 2020, recruitment for this trial was ongoing.39,40

The metastatic urothelial cancer cohort of the IM-T-IMMU-132-01 trial reported encouraging activity with sacituzumab govitecan-hziy monotherapy (ORR, 31%; median PFS, 7.3 months; and median OS, 18.9 months).41Sacituzumab govitecan-hziy has FDA fast track desig-nation for metastatic urothelial cancer and is currently under further investigation in the phase 2 TROPHY U-01 trial (NCT03547973) and the upcoming phase 3 TROPiCS-04 trial (NCT04527991).42-45

Final data for cohort 1 and the trial design for cohort 3 were presented at the ESMO Virtual Congress 2020 for the pivotal phase 2, open-label, multicohort TROPHY U-01trial. The TROPHY U-01trial is investigating the safety and efficacy of sacituzumab govitecan-hziy in patients with heavily pretreated metastatic urothelial cancer across several cohorts. The study population across the TROPHY U-01 trial includes patients with disease progression despite treatment with platinum (PLT)-based chemotherapy, checkpoint inhibitors, or both. For all cohorts, the primary efficacy end point is ORR, and key secondary end points include PFS, OS, duration of response, and safety analyses.44,45

Cohort 1

Cohort 1 included a total of 113 patients who were treated with sacituzumab govitecan-hziy. The study population included patients who experienced disease progression after both PLT-based chemotherapy and checkpoint inhibitor therapy.44 Overall, patients in cohort 1 were previously treated with a median of 3 therapies and were a median of 66 years of age. In the results presented at ESMO 2020, a total of 31 patients had achieved an objective response (ORR, 27%; 95% CI, 19%-37%), of which 6 were complete responses and 25 were partial responses. The median duration of response was 5.9 months (95% CI, 4.7-8.6); median PFS and OS were 5.4 months (95% CI, 3.5-6.9) and 10.5 months (95% CI, 8.2-12.3), respectively. Sacituzumab govitecan-hziy demonstrated manageable toxicity. Key grade 3 or higher AEs were neutropenia (35%), anemia (14%), febrile neutropenia (10%), and diarrhea (10%).44

Cohort 3

As of March 2020, cohort 3 had started enrollment and is ongoing. The study plans to enroll a total of 61 patients with metastatic urothelial cancer who are nave to checkpoint inhibitor agents and have experienced disease progression or recurrence after PLT-based chemotherapy.45 As checkpoint inhibitors are the stan-dard-of-care therapy for patients who have failed on PLT-based chemotherapy, this study will investigate combination therapy with sacituzumab govitecan-hziy and the checkpoint inhibitor pembrolizumab. Exclusion criteria include active autoimmune disease or a history of interstitial lung disease, given the coadministration of pembrolizumab. A 10-patient lead-in cohort will determine standard the recommended phase 2 dose of sacituzumab govitecan-hziy (given on days 1 and 8 of 21-day cycles), to be given along with pembrolizumab 200 mg on day 1 of each cycle. The primary end point of ORR and secondary end points of PFS, OS, clinical benefit rate, duration of response, and safety will be assessed.45

The phase 3, global, open-label TROPiCS-04trial aims to enroll 482 patients to investigate the efficacy and safety of sacituzumab govitecan-hziy in patients with metastatic or locally advanced unresectable urothelial cancer who have progressed despite prior therapy with PLT-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor. Sacituzumab govitecan-hziy will be compared with physicians choice of chemotherapy (paclitaxel, docetaxel, or vinflunine). The primary outcome measure will be OS; secondary outcomes will include PFS, ORR, safety, and quality of life. As of August 2020, the trial was not yet recruiting patients.43

Evaluation of novel and existing ADCs has revealed that success is not based on the use of any one particular cytotoxic compound or conjugate platform. Factors such as the consistency and level of target-antigen expression, tumor progression, and specific properties of the cancer and stage of disease also play important roles.46 Several additional Trop-2targeted ADCs are currently being investigated in solid tumors (Table).33,36,37,40,42,43,47-51

DS-1062a is a Trop-2directed ADC that contains the cytotoxic compound DXd, a derivative of exatecan that acts as a DNA topoisomerase I inhibitor.52 It is currently being investigated for the treatment of advanced NSCLC in an ongoing phase 1, multicenter, open-label study (NC T 03 401385).48

The study involves a dose-escalation phase and a dose-expansion phase. Dose-limiting toxicity, maximum tolerated dose, and AEs will be explored in both phases.47 Eligible patients have experienced disease progression or recurrence despite previous treatments, have measurable disease per RECIST 1.1 criteria, and are able to provide a sufficient tumor tissue sample for Trop-2 measurement. Patients with multiple primary malignancies or untreated brain metastases are ineligible for the study.48

As of November 2018, a total of 22 patients had been treated with 1 of 3 escalating doses of DS-1062a. Nearly 82% of patients experienced at least 1 treatment-emergent AE, with fatigue being the most common complaint. Fatigue was the only reported grade 3 or higher AE and was reported by 1 patient. Of 18 tumor-evaluable patients, 1 showed a partial response and 8 showed stable disease. Maximum-tolerated dose has not been achieved, and investigators will continue to monitor for safety and disease progression.47, 48

RN927C

RN927C, also known as PF-06664178, is an ADC composed of a Trop-2directed antibody conjugated with the cytotoxic microtubule inhibitor PF-06380101. Release of PF-06380101 leads to mitotic arrest, apoptosis, and cell death.3 Preclinical studies demonstrated the ability of RN927C to induce cell death among various tumor cell lines, including those from the skin, lung, head and neck, breast, ovary, and colon.3

RN927C was investigated in a phase 1, open-label, nonrandomized dose-escalation study (NCT02122146)of patients with advanced or metastatic solid tumors that were unresponsive to current therapies or for whom no standard therapy was available. The primary objective of the study was to determine the maximum tolerated dose and recommended phase 2 dose. Secondary outcomes included safety and preliminary evidence of antitumor activity. A total of 31 patients were enrolled and received treatment with escalating doses of RN927C. Stable disease was noted in 11 patients (39%), but no partial or complete responses were seen. Doses of 3.6 mg/kg, 4.2 mg/kg, and 4.8 mg/kg were considered intolerable, primarily because of skin reactions and development of neutropenia. The next-lower dose of 2.4 mg/kg was well tolerated, but the study was terminated early because of minimal anti-tumor activity and excessive toxicities.50

BAT8003

BAT8003 is an ADC composed of a Trop-2directed antibody conjugated to a potent cytotoxic maytansine derivative. The ADC has been optimized to facilitate site-specific conjugation, which allows for a more controllable drug-antibody ratio. In addition, a fucosylation of the Fc region of the antibody enhances its antibody-dependent cell-mediated cytotoxicity effect. In preclinical xenograft and primate models, BAT8003 demonstrated strong inhibition of tumor growth at doses of 5 mg/kg and 15 mg/kg, with a highest nonseverely toxic dose of 20 mg/kg given once every 3 weeks.51, 53

Given the promising preclinical data, a phase 1 dose-escalation study (NCT03884517) is currently investigating the safety, tolerability, and pharmacokinetics of BAT8003 in patients with advanced epithelial cancer who are either ineligible for standard therapy or have disease refractory to standard therapy.Eligible patients will receive escalating doses of BAT8003 (0.2-10.0 mg/kg) on day 1 of each 21-day cycle. The study will be divided into 3 periods: (1) the first 21-day cycle, which will examine the safety of a single BAT8003 administration, observe for dose-limiting toxicities, and establish preliminary pharmacokinetic parameters; (2) cycles 2 through 8, which will examine safety, immunogenicity, and preliminary efficacy of escalating doses of BAT8003; and (3) an expansion period, which could include an additional 10 to 30 cases to further assess safety and efficacy once a safe and effective dose has been established. As of the last update on March 21, 2019, the trial was actively recruiting patients.51

Trop-2 has established itself as a clinically meaningful biomarker among several types of solid malignancies. Its ability to promote self-renewal, proliferation, and cell invasion makes it an ideal candidate for targeted anti-tumor therapies, including ADCs.

Sacituzumab govitecan-hziy is the first Trop-2directed ADC to receive FDA approval for the treatment of metastatic TNBC. In the pivotal IM-T-IMMU-132-01 trial, sacituzumab govitecan-hziy showed encouraging results in patients with multiple difficult-to-treat solid tumor types, including TNBC, HR+/HER2- metastatic breast cancer, and metastatic urothelial cancer.31,32,41 Sacituzumab govitecan-hziy and other Trop-2directed ADCs represent a novel strategy to improve outcomes among these populations of patients with few therapeutic options. Data from additional trials of sacituzumab govitecan-hziy were presented at the ESMO Virtual Congress 2020. In the ASCENT trial, sacituzumab govitecan improved response rates and survival outcomes in patients with metastatic TNBC compared with standard-of-care therapy.35 Data from a cohort of patients with metastatic urothelial cancer in the TROPHY U-01 trial indicated positive survival impacts with manageable toxicity.44 Additional trials of sacituzumab-govitecan-hziy (as monotherapy or in combination with PARP inhibitors or checkpoint inhibitors) are under way in patients with metastatic TNBC, breast cancer brain metastases, and metastatic or locally advanced urothelial cancer.37,40,43,45 Other Trop-2directed ADCs are under investigation in NSCLC and advanced epithelial cancers.47, 51

Read more:
Role of Trop-2 as an Actionable Biomarker in Solid Tumors - OncLive

By Stephanie Bowens| StarNews Correspondent

Polycystic Ovary Syndrome is one of the most common, yet treatable, causes of infertility in women. PCOS affects 1 in 10 women of childbearing age, according to the Office On Womens Health, and women who have the condition experience hormonal imbalance and metabolism problems that may affect their appearance and overall health.

Dr. Nicholas Bodenheimer, DO, an obstetrician-gynecologist withNovant Health OB/GYN Bolivia, said hes treated many women who have PCOS. He said the condition is typically characterized by hyperandrogenism, or elevated levels of androgens, such as testosterone, irregular or no menstrual periods and polycystic ovaries revealed on an ultrasound. Bodenheimer said despite the name, you dont have to have polycystic ovaries or small cysts on yourovaries to be diagnosed with PCOS. He recommends women discuss their concerns with a gynecologist.

1. Imbalances of hormones, including insulin and testosterone, play key role in PCOS symptoms.

The exact cause of PCOS is unknown. However, PCOS is associated with insulin resistance, obesity and high levels of androgens.

Androgens, often called male hormones, are hormones, such as testosterone, that are important for normal male sexual development, but women also make small amounts of androgens. Androgens control development of male traits, and women with PCOS have more androgens than normal.

Normally, in healthy women testosterone is largely bound by a protein called sex hormone binding globulin, leaving just a very small amount of freely circulating bioactive free testosterone. However, insulin resistance can disrupt this, and Bodenheimer said many women with PCOS have insulin resistance. Insulin resistance can cause a low level of sex hormone bind globulins, Bodenheimer said. So, if you have a low level of that you have an increase of testosterone in the body which can lead to hyperandrogenism.

Insulin resistance refers to when the bodys cells do not respond normally to insulin, a vital hormone that regulates blood sugar (glucose) in the body.

2. Irregular menstrual cycles are common symptoms of PCOS.

Higher than normal androgen levels in women can prevent the ovaries from releasing an egg (ovulation) during each menstrual cycle.

Bodenheimer said PCOS symptoms that often bring patients in to see him include excessive facial hair growth, absence of a menstrual period, irregular menstrual bleeding, or unsuccessfully trying to get pregnant for over a year. We see a lot of different types of clinical manifestations from PCOS, but probably the most common we see are menstrual disorders, Bodenheimer said. That can range from irregular menstrual periods to heavy menstrual periods to someone who is not having any menstrual periods. If we see women who are anovulatory, meaning they arent having regular menstrual cycles, that can lead to infertility.

Bodenheimer said usually in a 28-day cycle around cycle day 14 a woman ovulates so an egg is released. If someone is not ovulating, the egg is not released, he said. Thats how that leads to infertility.

Bodenheimer said there are various treatment options for infertility caused by PCOS.

3. PCOS often causes abnormal hair growth.

Bodenheimer said, for women with PCOS, increased levels of testosterone in the body can lead to excessive hair growth on their arms and face as well as acne. According to OWH, the excessive hair growth is called hirsutism and affects up to 70 percent of women with PCOS, causing them to have too much hair on the face, chin, or parts of the body where men usually have hair, and acne can appear on the face, chest, and upper back.

According to the OWH, other symptoms of PCOS include thinning hair, hair loss on the scalp or male-pattern baldness, weight gain or difficulty losing weight and darkening of skin, particularly along neck creases, in the groin, and underneath breasts.

4. Research has linked PCOS to other health problems, such as hypertension and sleep apnea.

According to OWH, studies have found links between PCOS and diabetes, high blood pressure and unhealthy cholesterol, sleep apnea, depression and anxiety and endometrial cancer. OWH indicates more than half of women with PCOS will have diabetes or prediabetes before age 40, and women with PCOS are at higher risk for high blood pressure compared with women of the same age without PCOS.

Problems with ovulation, obesity, insulin resistance, and diabetes, which are all common issues in women with PCOS, increase the risk of developing endometrial cancer, according to OWH.

Additionally, Bodenheimer said, For women with PCOS who do get pregnant we see increased risk of gestational diabetes as well as hypertensive disorders such as preeclampsia.

5. PCOS treatment focuses on managing symptoms.

Bodenheimer said treatment for PCOS focuses on treating and managing patients symptoms. When developing a treatment plan, the physician typically considers the patients symptoms, their plans for having children, and the patients risk of long-term health problems such as diabetes and heart disease.

If patients desire future fertility and are planning to become pregnant, then we see if they are ovulating or not, and we can usually do that by checking lab work, he said. If we are treating someone with PCOS who is not ovulating, we can treat them with medicine to help them ovulate, he said.

But Bodenheimer said one of the risks of using fertility drugs include pregnancy with multiples, such as twins.

If they are not desiring fertility in the immediate future, then we try things like birth control pills to help regulate those menstrual periods, Bodenheimer said.

He said he also sometimes discusses lifestyle modifications, including diet and weight loss. Some studies show losing five to 10 percent of their current body weight may induce spontaneous ovulation again, he said.

Read the original here:
5 things to know about Polycystic Ovary Syndrome - StarNewsOnline.com

Metabolic Renewal is a weight loss program designed specifically for women.

The program aims to boost your metabolism by modifying your diet and exercise routine based on your specific hormone type. Yet, the science behind these claims is suspect.

Despite several downsides, it has become popular among those looking to enhance their energy levels, curb cravings, and promote overall health.

This article examines the pros and cons of Metabolic Renewal to determine whether you should give it a try.

BOTTOM LINE: While Metabolic Renewal may promote short-term weight loss, many aspects of the plan arent backed by evidence. Additionally, its difficult to sustain long term and may lead to weight regain once you resume a normal diet.

Metabolic Renewal was designed by Dr. Jade Teta, an integrative physician who specializes in natural health and fitness. The program is intended to optimize womens metabolism using Dr. Tetas 4 M framework Mindset, Movement, Meals, and Metabolics.

The idea that seven distinct hormone types exist is central to the program, as well as that determining your specific hormone type may enhance your metabolism.

Metabolic Renewal offers a 12-week meal plan with recipes tailored to your hormone type.

It also includes access to a collection of 15-minute workouts, along with guidebooks on balancing hormone levels and eliminating belly fat.

Metabolic Renewal is a weight loss program that claims to optimize womens metabolism based on hormone type.

The first step of Metabolic Renewal is to determine your hormone type using their online quiz, which collects information about your age, menstrual cycle, medical history, and health goals.

A guide called The Hormone-Balancing Roadmap provides detailed information on how to follow the plan depending on your hormone type.

Meal plans are based on what Dr. Teta calls the 3-2-1 Diet, which provides three meals per day, two of which contain only protein and vegetables and one of which offers a small portion of starch.

The program includes a detailed meal plan with recipes, but youre permitted to create your own meals based on the 3-2-1 Diets principles, adding snacks as needed.

Metabolic Renewal also includes a 12-week workout plan thats divided into 4 phases. Throughout the program, youre required to exercise for 15 minutes 3 times per week using the plans Intelligent Workouts, which claim to combine resistance and cardio training.

On your days off, youre encouraged to walk for a set amount of time thats determined by your hormone type. Doing so is said to help maintain any changes to your metabolism.

Furthermore, Metabolic Renewal offers a private online community for its customers.

Metabolic Renewal provides a custom meal plan and exercise regimen based on your supposed hormone type.

Metabolic Renewal doesnt eliminate any foods outright but encourages a low carb, high protein diet. Fruits, grains, fats, and oils can all be enjoyed in moderation.

While no foods are banned, you should limit processed foods and items high in carbs and sugar.

Metabolic Renewal doesnt eliminate any foods outright but encourages you to restrict your intake of processed and high carb foods. Instead, youre meant to emphasize vegetables and high quality proteins.

Although Metabolic Renewal hasnt been studied specifically, it may offer several health benefits.

Several aspects of the program may aid short-term weight loss.

For starters, Metabolic Renewal encourages a diet rich in unprocessed whole foods, including meat, fish, poultry, and vegetables.

These foods are not only often lower in calories than processed foods but also rich in important nutrients like vitamins, minerals, and antioxidants.

Additionally, some research links a lower intake of processed foods to a decreased risk of obesity (1).

Metabolic Renewal is also low in carbs, with most meals consisting of vegetables and a source of protein. Some studies show that low carb diets promote short-term weight loss and fat loss (2, 3).

Whats more, increasing your protein intake may keep you feeling full for longer, which likewise supports weight loss (4).

Metabolic Renewal doesnt require you to count calories, measure your food, or track macronutrients. It also offers several ways to customize your meal plan, making it a good fit for those who prefer more flexibility.

In fact, you can easily swap in other recipes from the meal plan or create your own meals using the basic principles of the diet.

Plus, it offers options for paleo, keto, vegan, and vegetarian diets.

Although no studies have examined Metabolic Renewal, its very flexible and may promote weight loss at least in the short term.

Although Metabolic Renewal may offer some benefits, theres no evidence to support many aspects of the plan.

The idea that there are seven specific female hormone types isnt backed by science.

In fact, most of the benefits of this program are likely due to its diet and lifestyle changes not optimizing female metabolism.

The programs quick, 15-minute workouts that take place 3 times per week are said to maximize efficiency without stressing your metabolism.

While this idea may appeal to some people, it may be unsuitable for those who are more physically active or prefer certain workouts, such as cardio or weightlifting.

Metabolic Renewal retails for $67, which includes either online access or the printed program and set of DVDs.

This price tag is higher than many other programs, so its an important consideration for those on a tight budget.

Keep in mind that Metabolic Renewal is a short-term program designed to be followed for 12 weeks.

Although many short-term diets lead to rapid weight loss, youre likely to regain weight after you resume a normal diet. Thats partly because brief dietary changes dont often translate to long-term lifestyle habits (5).

Several core elements of Metabolic Renewal are scientifically suspect, including the concept of specific hormone types. Furthermore, the diet is expensive and may lead to weight regain.

Metabolic Renewal provides a 12-week meal plan, although you can still create your own meals using the basic principles of the diet.

Here is a sample 3-day meal plan for Metabolic Renewal.

The sample menu above details some of the meals that you can enjoy on Metabolic Renewal, including breakfast smoothies and dishes packed with veggies and protein.

Metabolic Renewal is a program intended to optimize womens metabolism by making changes to their diet and exercise routine.

Although the diet is very flexible and may lead to short-term weight loss, many aspects are rooted in unfounded health claims. Furthermore, its short-term nature makes weight regain likely once you resume a normal diet.

Here is the original post:
Metabolic Renewal Review: Pros, Cons, and Effectiveness - Healthline

We are always living in a state of survival. This might be any type of chronic illness, virus or maybe a lifestyle related disease. Whatever it is, fasting can help with many health issues and in addition can help with strengthening your immune system. I think if you try it you will be surprised by the benefits that you see, even if you are practicing time-restricted feeding (TRF) eating within the same time window each day, for example have a 12 hour period in which you eat, and the other 12 hours of the day in which you eat nothing. This will lead to more conscious eating habits as well.

Studies have shows how especially after a 72 hour water only fast the immune system strengthens and even the metabolism slightly increases. I dont suggest that length of fast for everyone, however you still can practice fasting for improving your health.

I love the fasting lifestyle for so many reasons, including:

Improving immunity

Efficiently cleaning up dead cells

Improving digestion

Reducing the risk of many types of cancer

Slowing down the aging process

Its an easy way to lose fat

It helps regulate your hormones

Its convenient

You can save time from cooking and shopping

Its easy to do, no matter which diet you choose to follow

And its all under your control

Heres a few suggestions if you would like to try it:

If you want to try longer than 18 to 20 hours then make sure that you listen to your body. If you experience any dizziness, diarrhea, headaches or stomach pain then its time to stop, break your fast, and try again next time.

If you are taking medication then you must let your physician know before you practice fasting.

Identify your goals why would you like to practice fasting? For example, are you doing it to heal your diabetes, or just to lose a few pounds, or maybe for some more serious health problems? You need to know what type of fasting schedule is the best for you.

Women can be much more sensitive to fasting, although it is great for balancing hormones. So its very important, especially for women, to break the fast with a low carbohydrate, high protein, and moderate fat meal. This can help not to raise insulin (the fat storage and blood sugar regulating hormone) so quickly.

During the fast you generally dont need any supplements. However, it depends on the length of your fast. If you are fasting for longer than 20 hours you may need to supplement with salt, potassium chloride, and magnesium. When you are doing fasting the body uses glycogen (sugar) for energy which, depending on your bodys state, can take 20 to 36 hours. Each gram of glycogen in the cell holds about 3 grams of water, so when you deplete your glycogen storage you also lose electrolytes too. Thats why you may feel low energy, brain fog and a little dizzy too.

Probably you now understand that I am really a fan of water only fasting. This can be done daily, for example a daily 14 hour fast and then 10 hours in which to eat your meals. Or it can be done as prolonged fasting. You just need to be sure that you know why youre doing it and what you want to achieve so you can make your own fasting schedule.

Fasting is free so just try it out, and if you dont like it then change your schedule. Just pay attention your body, it will tell you whats best.

Resources:

Intermittent fasting: Surprising update

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4808902/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478699/

Fasting for 72 hours can reset your entire immune system (The Source)

Fasting triggers stem cell regeneration of damaged, old immune system

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4102383/

Ayda Ersoy, nutritionist (Dip.C.N., Dip.S.N.), master trainer (CPT ACE, NCSF, CanfitPro), registered yoga teacher, founder, Health Angel Nutrition, Fitness and Wellness, founder, SMS (Stability, Mobility Strength) Intuitive Training System.

See original here:
Fasting is one of the easiest ways to strengthen immunity - The Garden Island

Hormones are natural substances made by our glands in our body and the network of glands that make hormones is termed as endocrine systems. These hormones are carried through bloodstream and act as a messenger between one part to another part of our body. Hormone therapy is one of the major modalities of medical treatment for cancers which involves manipulation of the endocrine systems through exogenous administration of steroid hormones or drugs inhibiting or interrupting activities of specific hormones.

Read Report Overview https://www.transparencymarketresearch.com/cancer-hormone-therapy-market.html

Surgical removal of certain endocrine organs for instance oophorectomy can also be employed as a part of hormone therapy. In hormone therapy physician generally start with hormone receptor test that let caregivers to measure amount of cancer proteins or hormone receptors within a cancer tissue. By estimating the amount of hormones such as estrogen or progesterone the test either can be positive or negative. A positive test indicates growth of cancer cells with the help of hormones.

In such cases physician divert the hormone therapy by blocking the interaction of hormones with the hormone receptor. Alternatively, in case of negative hormone receptor test which signifies null effect of hormones in growth and development of cancer cells other effective treatments can be rendered to cure cancer.

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A hormone therapy can be rendered either before or after a primary treatment. In case it is rendered before the primary treatment it is medically termed as neoadjuvant treatment which kills. Neoadjuvant treatments help to kill cancer cells and contribute to the effectiveness of the primary therapy. If hormone therapy is given after the primary cancer treatment, it is called adjuvant treatment. Adjuvant therapy is given to improve the chance of a cure.

Now a day hormone therapy is widely used in treating breast and prostate cancer. In breast cancer the female hormone estrogen are primarily responsible for stimulating the growth and development of breast cancer cell in majority of cases. Recently in 2014, aromatase inhibitors such as Arimidex and Femara have been approved for treating breast cancers through hormone therapy. Apart from these FDA approved Zoladex Lupron can also be used in curing breast cancers through hormone therapy. In case of prostate cancer a variety of medications can be used as hormone therapy.

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Male hormones, such as testosterone, stimulate prostate cancer to grow. Hormone therapy is given to help stop hormone production and to block the activity of the male hormones. Some of the antiandrogens used as inhibitors of prostate cancer cell growth encompass flutamide, enzalutamide, bicalutamide, and nilutamide among others. some of the other cancers to which hormone therapy is gaining acceptance now a day include womb cancer, kidney cancer, ovarian cancer among others.

Major drivers to global cancer hormone therapy include rising incidences of cancer across globe. Statistically according to WHO cancer accounts for 8.2 million deaths in 2012 and it is estimated that annual cancer cases is expected to rise from 14 million in 2012 to 22 million by 2022. Rising awareness among physician and patients towards alternative cancer therapy processes such as target therapy, immunotherapy or hormone therapy is likely to uplift the market in forthcoming years.

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Side-effects associated with hormone therapy are major restraints to growth and acceptance of therapy. Some of the common side-effects associated with hormone therapy for cancer include nausea, vaginal spotting, irregular menstrual periods, skin rashes, loss of appetite, vaginal dryness, impotence and male breast enlargement among others.

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Cancer Hormone Therapy Market : Industry Overview, Trends and Growth Opportunities Forecasted Till 2024 - The Think Curiouser

This post was contributed by a community member. The views expressed here are the author's own.

On Sunday, November 1st, at 2 am, clocks will be turned one hour back for Daylight Savings Time, so when the clock reads 10 am on Sunday morning, your brain and body will insist that it is really 11 am.

"Gaining' an hour in the fall is much easier for our bodies than 'losing' an hour in the spring," says Dr. Praveen Rudraraju, medical director of the Center for Sleep Medicine at Northern Westchester Hospital. "For many, sleep has become more elusive in these uncertain times.

"Sleep specialists are seeing an unprecedented numbers of patients suffering from insomnia and other sleep disturbances due to the pandemic, which presents a unique set of multiple stressors," he adds. "There's no quick fix for the anxiety that's keeping people awake as they worry about their jobs, income, the health and safety of loved ones, social isolation and an uncertain future. There is actually a hormonal basis for this kind of insomnia. Anxiety triggers the production of stimulating chemicals in the body that keep people awake.

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To get the most out of sleep, Dr. Rudraraju says that both the quality and quantity are important. Most adults need seven to eight hours of sleep in order to feel refreshed and alert. Sleeping less than five hours a night can raise the risk of cardiovascular disease by 40 percent, while chronic insomnia quadruples the risk of stroke. Numerous studies have linked poor-quality sleep to weight gain. Ghrelin, a hormone linked to hunger, increases when people sleep poorly.

Dr. Rudraraju advises people to practice good sleep hygiene:

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If you often wake up groggy, have trouble falling asleep or staying asleep, feel sleepy all day long or snore, you may need a sleep study to assess the possibility of a sleep disorder. An at-home sleep study can find out if you do have a sleep issue, but an in-hospital sleep study can diagnose whether it is caused by an underlying medical condition.

One of the most common disorders is sleep apnea, typically characterized by loud snoring and feelings of constant tiredness. The condition interrupts a person's breathing hundreds of

times a night, depriving the brain and heart of oxygen. Untreated sleep apnea increases the risk of high blood pressure, heart attack, stroke, obesity, diabetes and mental illness. It also puts people at increased risk of heart failure, arrhythmias or irregular heartbeats, and increases the risk of driving accidents.

For more information or to make an appointment for a sleep center study, visit nwh.northwell.edu/sleep-center or call 914-666-1114.

About Northern Westchester Hospital

Northern Westchester Hospital (NWH), a member of Northwell Health, provides quality, patient-centered care that is close to home through a unique combination of medical expertise, leading-edge technology, and a commitment to humanity. Over 650 highly-skilled physicians, state-of-the-art technology and professional staff of caregivers are all in place to ensure that you and your family receive treatment in a caring, respectful and nurturing environment. NWH has established extensive internal quality measurements that surpass the standards defined by the Centers for Medicare & Medicaid Services (CMS) and the Hospital Quality Alliance (HQA) National Hospital Quality Measures. Our high-quality standards help to ensure that the treatment you receive at NWH is among the best in the nation. For more information, please visit http://www.nwhc.net and connect with us on Facebook.

About Northwell Health

Northwell Health is New York State's largest health care provider and private employer, with 23 hospitals, nearly 800 outpatient facilities and more than 14,200 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 72,000 employees 17,000-plus nurses and 4,500 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better. We're making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, Twitter, Instagram and LinkedIn.

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Black licorice may look and taste like an innocent treat, but this candy has a dark side. On Sept. 23, 2020, it was reported that black licorice was the culprit in the death of a 54-year-old man in Massachusetts.

How could this be? Overdosing on licorice sounds more like a twisted tale than a plausible fact.

I have a longstanding interest in how chemicals in our food and the environment affect our body and mind. When something seemingly harmless like licorice is implicated in a death, we are reminded of the famous proclamation by Swiss physician Paracelsus, the Father of Toxicology: "All things are poison, and nothing is without poison; the dosage alone makes it so a thing is not a poison."

I am a professor in the department of pharmacology and toxicology and author of the book Pleased to Meet Me: Genes, Germs, and the Curious Forces That Make Us Who We Are.

The unfortunate man who recently succumbed to excessive black licorice consumption is not alone. There are a smattering of similar case reports in medical journals, in which patients experience hypertension crisis, muscle breakdown or even death.

Adverse reactions are most frequently seen in people over the age of 40 who are eating far more black licorice than the average person. In addition, they are usually consuming the product for prolonged periods of time.

In the most recent case, the Massachusetts man had been eating a bag and a half of black licorice every day for three weeks.

Licorice is a flowering plant native to parts of Europe and Asia. Its scientific name, Glycyrrhiza, is derived from the Greek words "glykos" (sweet) and "rhiza" (root). The aromatic and sweet extract from its root has long been used as an herbal remedy for a wide variety of health maladies, from heartburn and stomach issues to sore throats and cough.

However, there is insufficient evidence to support that licorice is effective in treating any medical condition.

Glycyrrhizin (also called glycyrrhizic acid) is the chemical in black licorice that gives the candy its signature flavor, but it also leads to its toxic effects.

Glycyrrhizin mimics the hormone aldosterone, which is made by the adrenal glands when the body needs to retain sodium and excrete potassium. Sodium and potassium work together as a kind of cellular battery that drives communication between nerves and the contraction of muscles. Too much glycyrrhizin upsets the balance of these electrolytes, which can raise blood pressure and disturb the heart's rhythm.

Other symptoms of excessive licorice intake include swelling, muscle pain, numbness and headache. Examination of the man who died from consuming too much licorice revealed that he had dangerously low levels of potassium, consistent with glycyrrhizin toxicity.

It should be noted that a number of licorice-based foods do not contain real licorice, but use a flavoring substitute called anise oil, which does not pose the dangers discussed here. In addition, despite its name, red licorice rarely contains licorice extract. Instead, red licorice is infused with chemicals that impart its cherry or strawberry flavor.

Products that contain real licorice are usually labeled as such, and list licorice extract or glycyrrhizic acid among the ingredients. Be advised that some products, such as black jelly beans or Good & Plenty, are mixtures of different candies that contain both anise oil and licorice extract.

Licorice is produced from the Glycyrrhiza glabra plant. (Franz Eugen Khler/Khler's Medizinal-Pflanzen/Wikimedia)

Glycyrrhizin has the distinct licorice flavor and is 50 times sweeter than sugar and has been used in other types of candy, soft drinks, tea, Belgian beers, throat lozenges and tobacco.

This can make it challenging to keep track of how much glycyrrhizin has been consumed, and a combination of these products could trigger adverse effects.

Some people take dietary or health supplements that already contain licorice, which increases the risk of toxic effects from eating black licorice candy. Certain medications such as hydrochlorothiazide are diuretics that cause increased urination, which can lower potassium levels in the body.

Glycyrrhizin also lowers potassium levels, further disrupting the balance of electrolytes, which can produce muscle cramps and irregular heart rhythms.

People with certain preexisting conditions are more susceptible to black licorice overdose.

For example, patients who already have low potassium levels (hypokalemia), high blood pressure or heart arrhythmia are likely to have greater sensitivity to the effects of excessive licorice. Those with liver or kidney deficiencies will also retain glycyrrhizin in their bloodstream for longer times, increasing their risk of experiencing its adverse effects.

If you're a fan of black licorice, there is no need to ban it from your pantry. Eaten in small quantities from time to time, licorice poses no significant threat to otherwise healthy adults and children. But it is advisable to monitor your intake.

With Halloween approaching, be sure to remind your kids that candy is a 'sometimes food', especially the black licorice. The FDA has issued warnings about the rare but serious effects of too much black licorice, advising that people avoid eating more than two ounces of black licorice a day for two weeks or longer.

The agency states that if you have been eating a lot of black licorice and experience an irregular heart rhythm or muscle weakness, stop eating it immediately and contact your health care provider.

Some scientists have further cautioned against the routine use of licorice in the form of a dietary supplement or tea for its alleged health benefits.

A review article from 2012 warned that "the daily consumption of licorice is never justified because its benefits are minor compared to the adverse outcomes of chronic consumption."

Bill Sullivan, Professor of Pharmacology & Toxicology; author of Pleased to Meet Me: Genes, Germs, and the Curious Forces That Make Us Who We Are, Indiana University.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Can You Really Overdose on Black Licorice? Here's The Science on The Hidden Dangers - ScienceAlert

CARLSBAD, Calif., Oct. 28, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (Nasdaq: QLGN) today announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company's planned clinical development of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19.

The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials (for treatment of COVID-19) in the first half of calendar 2021, to be followed next by seeking to advance ALAN into clinical trials against acute myeloid leukemia. ALAN is AS1411 attached to a gold nanoparticle.

"We are delighted with the FDA's thoughtful and thorough response to our Pre-IND meeting request which provides a pathway for us to move forward with filing the IND application and initiation of a clinical trial in the first half of calendar 2021," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "We are in agreement with the FDA's additional recommendations and believe their responses provided the clarity needed to move forward to get AS1411 into clinical trials for the treatment of hospitalized patients with COVID-19.In addition, we look forward to further investigating the potential use of AS1411 as a broader spectrum antiviral therapeutic."

In its Pre-IND meeting request, the Company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19. The FDA's recommendation is to commence with a Phase 2a proof-of-concept study to evaluate safety and initial efficacy in determining the appropriate dose with outcomes assessed at Day 28. The Company and the FDA agree that a Phase 1 clinical trial is not needed here, because in a previous clinical trial against cancer AS1411 has already been shown to meet Phase 1 safety requirements.

"There continues to be a need for novel treatments for COVID-19," stated Paula Bates, PhD, Professor of Medicine at the University of Louisville, who co-invented the technology. "We know that nucleolin plays an important role in the infectivity of viruses and were able to demonstrate in our AS1411 preclinical studies, the aptamer was effective against the SARS-CoV-2 virus at doses indicated to be safe in humans by previous research. As a result, we believe AS1411 has the potential to be a promising therapeutic for COVID-19, as well as for other viral infections."

Extensive preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19. Qualigen has held an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive license agreement for the University of Louisville's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating or even preventing viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the timing of the filing and (if any) acceptance of an IND application for AS1411 as a therapy against COVID-19 and the timing of the related clinical trials (if any), and the possible effectiveness of AS1411 against COVID-19 or other viral infections. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products generally, particularly in view of COVID-19-related deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPackinstruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available atwww.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen, Inc.

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Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19 - PRNewswire

Its not often that breast cancer is overshadowed by another health crisis, but such is life in pandemic times. But what should never take a backseat where breast cancer is concerned is the importance of screening and prevention.

Screening for breast cancer is really important because, while it is quite common and can be deadly, when caught early it is much more treatable and less deadly, said Christy Bridges, a physicians assistant with the Orange County Health Department in Hillsborough. The idea for doing a screening is your looking at someone who doesnt have any symptoms and looking for a concern or a problem. Because you would only screen if you could do something about it. Breast cancer is a cancer we can do something about by screening.

The most-commonly used tool for breast cancer screening is the mammogram. It is recommend women of average risk for breast cancer start discussing screening with their care provider at age 40. Between ages 40 and 50 theres not a strong base of evidence showing any real benefit in undergoing a mammogram. After reaching age 50 the evidence is more clear that breast cancer screening with mammogram is effective. The recommendation of screening every two years with a mammogram starts at age 50.

Health care providers will order a mammogram for a patient. Many health care facilities, like UNC Healthcare, do mammogram screenings at multiple locations. The patient goes in for the mammogram and is given the results through a letter, or if there is a determination that additional follow up is needed, then that can be done either at the time of the screening or at a follow up appointment.

Its often believed that family history is a big factor in the likelihood of being diagnosed with breast cancer. But this is not necessarily so, said Bridges.

Most women who are diagnosed with breast cancer do not have a family history. For women who have a family history of breast cancer, we want to discuss that and its good for us to know that so we can determine if they would benefit from a specific, like targeted testing to determine if they have a genetic marker that makes them more of a risk. But the vast number of women who are diagnosed with breast cancer dont have a genetic history. While it is a risk factor, its not the only one.

As far as types of cancer, breast cancer is the most common of new cancer cases in North Carolina, according to 2017 statistics from the Centers for Disease Control, making it more common than lung and colon cancers. It is less deadly than lung cancer, but it still is the second-leading cause of cancer deaths in the state.

While there may not be much difference in the number of breast cancer cases, minorities often face a higher mortality rate.

What we unfortunately see sometimes is that breast cancer is diagnosed at a later stage in African American or Latino women, Bridges said. If youre diagnosed at a later stage, or a more advanced stage of breast cancer, that decreases your likelihood of surviving it. Women-of-color should take any breast cancer concerns seriously and take any opportunity for screening.

Surgery and surgery with radiation is the most common treatment for breast cancer, if it is caught early enough and before it has spread beyond the breast. If the cancer is a more spread, then chemotherapy can be used. Other treatments include hormonal therapy and targeted therapy. Although there are many layers of treatment for breast cancer, the message health professionals want to make clear is the earlier cancer is diagnosed, the easier the treatment tends to be.

For some risk factors, like age and family history, little can be done to decrease the the chance of a cancer diagnosis. But there are steps that can be taken to cut down on other risk factors.

Things you do have control over that are risk factors for breast cancer that someone can alter or change include not being physically active, Bridges said. Increasing your physical activity is protective from breast cancer. Being overweight is a risk factor. Keeping your weight to a healthy level is protective. Alcohol can be a risk factor. Hormonal therapy, like post-menopausal hormone replacement therapy that can be useful in certain instances, can also have some risks. Thats worth a discussion with your care provider.

One of the biggest risk factors is for women who are not connected with a health care provider, or are underinsured. One program that the Orange County Health Department participates in is the Breast and Cervical Cancer Control Program, or the BCCCP, which is a federal and state program with funding to help screen women for breast and cervical cancer who are underinsured or uninsured. The Orange County Health Department participates in the program to help women who may not have a health care provider or be connected to care.

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Screening the key to breast cancer prevention, treatment - newsoforange.com

The American Cancer Society recommends that all women over the age of 40 years should undergo regular breast screening and practice breast self-examination.

Over the years, breast cancer has become the nemesis of Indian women, overtaking cervical cancer to establish its dominance as the most common cancer in Indian women. The sheer number of cases is so huge that even with both sexes combined, breast cancer ranks as the number one among all cancers in terms of numbers. So, what causes it? Factors are numerous such as: 1) Prolonged exposure to oestrogen during reproductive phase of life which can be due to early menarche, late menopause, delayed child birth or lack of children etc; 2) Obesity; 3) Increased breast density; 4) Genetic mutations; 5) Familial mutations; and 6) Exposure to ionizing radiation.

Breast lumps, like most cancers, are silent killers. They sneak up stealthily on unsuspecting patients with painless, hard masses which are noticed accidentally only after they become big enough to be palpable. Diagnosis is further delayed by societal taboos and denial mentality of patients. Studies have shown that a number of factors such as educational status, religion, marital status and socio-economic status contribute to a delay in diagnosis of breast cancer in Indian women. Lack of education and low socio-economic status, contribute to avoidance of breast cancer screening and even if a mass is identified, these women are reluctant to seek medical help as they prioritize needs of family over theirs and fear the economic burden of medical treatment and loss of income as they would have to discontinue their jobs. Divorced and widowed women, especially in the older age group, often find themselves living alone without a support system. This results in a delay in seeking remedial therapy for any breast mass, even if they identify it at an early stage.

Another variable causing delay in diagnosis of breast cancer is the rampant use of alternative medicine. Many patients report to a doctor after having tried alternative therapies for resolution of mass. If the mass is malignant, the therapies dont work, causing tumor progression and often present as a metastatic disease. Indian women most commonly present as Stage IIb and above, unlike their western counterparts who undergo rigorous screening which helps in detecting small non-palpable tumours. In advanced disease, there maybe skin ulcers, nipple erosion, nipple inversion, bloody nipple discharge, bone pain, breathing difficulty, etc. It is high time that we educate our women, starting with our family members, about the value for routine screening of breast cancer and to ensure that they seek medical help at the earliest, if a mass is detected. Catching it early gives us the best shot at curing the disease completely.

The American Cancer Society recommends that all women over the age of 40 years should undergo regular breast screening and practice breast self-examination which is a series of simple steps that women can perform on themselves on a monthly basis to identify suspicious lumps. If a lump is identified, it is not a cause for panic. It is advisable to contact a family doctor or an oncologist, as most breast lumps, especially in younger age groups, are benign or harmless. The oncologist will examine the patient and advise a mammogram and needle evaluation of the breast lump, either as a Fine Needle Aspiration Cytology (FNAC) or Trucut biopsy, which yields more tissue. If malignancy is confirmed in the specimen, then further staging workup is done in the form of Ultrasound Abdomen, Chest X-ray, PET CT scan, etc. based on physicians judgment.

Treatment for breast cancer consists of the following modalities: Surgery, Radiation, Chemotherapy and Hormonal therapy, used in combination based on stage, tumour type, age and general condition of patient. Each of these treatment modalities can be further tailored for each patient. For patients who wish to preserve the breast, it is possible to so in early breast cancer by breast conservation techniques; similarly, chemotherapy drugs and regimens vary based on tumour types and its hormonal receptor markers. Radiation therapy has evolved over the years to become extremely precise, allowing patients to be treated with limited adverse events.

Once treatment is complete, patients have to be close follow up for a number of years. Some patients who have hormone receptor markers positive in their tumour tissue are advised to take hormonal therapy for 5-10 years.

In conclusion, breast cancer is not the death sentence it once was. Advanced treatment options have ensured that patients presenting at any stage can enjoy a long and healthy life. In the words of Cayla Mills, You never know how strong you are until being strong is the only choice you have. Help is at hand.

(Dr M Banu Priyaa is the Clinical Lead and Consultant Radiation Oncologist at Kauvery Cancer Institute, Chennai)

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How social stigma and delayed diagnosis affect Indian women with breast cancer - The News Minute

My very good friend Joanne recently revealed that she is starting radiation treatment for a very recent diagnosis of breast cancer. She found her lump and immediately contacted her physician. From then to now has been a whirlwind of activity. The area of concern started with an itch, but it really concerned her. Maybe it was imagination, she thought. She persisted, even when the mammogram wasnt seeing it. In this case her lump was positional undetectable when standing, but detectable when she leaned forward. It was tiny about half a centimeter (2.54 centimeters - 1 inch).

Joanne marked her area with a sharpie so radiographers would know. Her tumor is hormone (estrogen) driven. Ironically enough, Joanne always monitored her diet and instinctively avoided foods that promote hormones.

She eats much more healthy than I do. And she has no known family history. Her first treatment was Monday right before Breast Cancer Awareness Month October. The statistics are shocking 1 out of 8 women will suffer breast cancer. I wrote several columns on prevention in the past, and my information is meant to educate my readers. But I know it can strike anyone even those who eat a great diet and have a healthy lifestyle.

For those who are interested, there are foods and lifestyle practices that actually promote cancer, and then there are foods and lifestyle practices that can help prevent it. Lets review food and lifestyle practices that can PROMOTE cancer: High fat foods, nitrites (found in cured meat), eating the burnt part of charcoal grilled foods (acrolein), belly fat (look in a mirror), high levels of caffeine, cigarette smoking and second-hand smoke, heating foods in Styrofoam and plastic wraps, supplements containing boron and excessive use of soy, and even eating the same foods over and over. There is evidence that soy, mushrooms, broccoli and cauliflower, citrus fruits, flax seeds and fiber increase hormone production.

Then there are those that can PREVENT cancer: Eating more plant-based proteins (beans, legumes), drinking more water, a wide variety of fruits and vegetables especially those with deep colors (beets, winter squash, carrots), including fish at least weekly, eating low fat foods, eating more whole foods (a baked potato instead of French fries), using whole grains (rye or pumpernickel instead of plain white bread), eating a wide variety of foods (limits overexposure), staying physically active and achieving and maintaining a healthy weight range.

Joanne stresses the importance of self-detection. That, my dear readers, is just one more thing that we need to do on a regular basis. But it is so important. I have a monthly note on my Calendar in my iPhone to remind me to self-examine on the first of the month. Get familiar with what is normal and then pay attention to any changes. Johns Hopkins Medical Center states, Forty percent of diagnosed breast cancer are detected by women who feel a lump. Its also important to do a monthly visual inspection, too. You can Google how to perform the self-exam, which is recommended to do while in the shower.

As far as diet changes Plan at least one plant based dinner weekly beans and greenspasta and tomato sauce?? Thats easier on your pocketbook, too. Use baby carrots, apples, grapes, cut-up green peppers as snacks instead of chips and dip. Substitute flavored herbal teas for coffee and soda. Carry a water bottle around to have ready access to a healthier no calorie beverage. Use whole foods more in your meal preparation. It only takes 4 minutes to nuke a whole potato. Lets make surviving the easier option. Continue with PINK POWER!! And Im praying for my friend.

Jeannie Wolcott, RD, CDN, is a retired registered dietitian, licensed Zumba (R) instructor for adults and kids, and a coordinator of Old Forestport Days.

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Eating healthier can reduce the risk of cancer - Rome Sentinel

FeaturesKieran Khan6 Hrs AgoLicensed naturopathic physician Dr Anna Maria Pouchet says people don't realise how seemingly little things impact them and make them susceptible to cancer. Photo courtesy Dr Anna Maria Pouchet

The key approach to dealing with cancer will always be with prevention," explained Dr Anna-Maria Pouchet, a licensed naturopathic physician with the Hope and Wellness Clinic, "and it starts with the things that many women and men overlook in their everyday life. They dont realise how seemingly little things impact them and make them susceptible to cancer.

Turmeric is a natural herb that can be used in the fight against cancer. Image taken from cdn-prod.medicalnewstoday.com

We need to be more aware how our cell phones, the lotions containing parabens, nail polishes, birth control tablets, laundry detergent, fabric softeners, bleach, and even the plastic bottles we drink from every day are impacting on our life as much as the antibiotics and pesticides in our foods are too.

The cancer-environment connection

Pouchet's view of the world we live in is echoed by dozens of documentaries and hundreds of research papers. Human beings are destroying the planet in a way that it is also in turn destroying us.

We are aware of the oestrogen hormone, but what people fail to recognise is that the amount of hormones produced in our bodies is so minimal but we absorb additives to our beauty products and our food, (and) in particular oral contraceptives, that contain milligrams of synthetic hormones milligrams when our bodies dont even need these amounts, she pointed out.

The result is that our kidneys and liver are overburdened by the detoxification of all (these) toxic chemicals, including excess hormones, and eventually we become nutrient-depleted by the process of eliminating and begin to store many of these in our fatty tissue which for women often means in the breasts and other areas like the hips, butt and thighs.

"Toxins also cause damage to our DNA and as a result our cells are not able to regulate and eventually mutate and become malignant, she elaborated.

Pouchet focuses on helping the body to function in the right way with proper diet, nutrition, detoxification, and supplementation, as needed.

Our hormonal balances are dependent on having proper functioning of our liver, kidney and a good gut flora so that we process and eliminate toxins. To achieve that you want to ensure you have sufficient intake of fibre and basic nutrients such as zinc, B vitamins, magnesium, etc.

"I highly recommend flaxseed or chia seeds daily along with lots of water. When it comes to water you also want to filter your water as best as you can. Flaxseed contains Omega-3 fatty acids and is especially important, in that it binds to excess oestrogen in the GI tract and gets it out the body.

Oral contraceptives contain synthetic hormones. Image taken from flushinghospital.org

According to LiveStrong.com, lignan by-products are known to bind to the oestrogen receptors found in body tissues, shifting oestrogen production to weaker forms which do not enhance cancer cell growth. The lignans found in flax may also inhibit aromatase, an enzyme which produces oestrogen.

Pouchet also advises everyone to invest in their health with good quality daily vitamin and mineral supplements to avoid nutritional deficiencies, even if they think they eat well.

And what if you are diagnosed?

Depending on the stage of the cancer and the size of the tumour as well as the course of treatment chosen, there is a lot that you can do for yourself to help you beat cancer.

Pouchet says, Research shows that there are herbs that work with the chemotherapy synergistically, which help to protect your healthy cells while they go through the process. There are also natural herbs that fight cancer and should be used for prevention of tumours, like turmeric, green tea, aloes, ginger, for example.

People living with cancer also struggle to get the daily intake of nutrients needed to fight the disease. Pouchet suggested supplementing as needed, and avoiding sugar, refined carbohydrates and, as far as possible, to turn to steamed cruciferous vegetables and probiotics to fuel and feed the gut lining, which is damaged by chemotherapy.

The emotional connection

In addition to diet and exercise, there is one key area Ikeen to learn Pouchet insights on cancer and its emotional roots. There are areas of research that link the onset of cancer to emotional disturbances or upheavals in peoples lives.

Pouchet agrees.

There is absolutely a connection. Many natural oncologists point out that cancer starts with the collapse of the nervous system or the sympathetic and parasympathetic systems in our bodies. The autonomic nervous system regulates many bodily functions, and they have links to every organ, especially our digestion.

According to licensed naturopathic physician Dr Anna Maria Pouchet, flaxseed contains Omega-3 fatty acids and binds to excess oestrogen in the GI tract and gets it out the body. Image taken from cdn-prod.medicalnewstoday.com

"From my own work I have seen patients that point out that there was a divorce or some form of recent conflict in their lives prior to their diagnosis. Negative emotions are involved in the breaking down of how the body protects itself and can create openings for the emergence of cancer, she said.

Given the emotional disturbances brought on by the covid19 pandemic, keeping positive eating habits and healthy exercise regimens should be an area of focus for everyone.

Though covid19 dominates our headlines, lifestyle diseases are still the leading causes of preventable death in TT.

Dr Anna Maria Pouchet is a licensed as a naturopathic physician by the State of Washington who practises in Trinidad. Education and medical training was at Bastyr University, which is one of four accredited naturopathic programmes in the US and internationally recognised as a pioneer in the natural sciences. Always consult a medical doctor or nutritionist before starting major diet changes.

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Cancer, naturopathy and emotional roots - TT Newsday

While antibody-drug conjugates (ADCs), such as fam-trastuzumab deruxtecan-nxki (Enhertu), may have shown efficacy in patients with HER2-low breast cancer in initial studies, according to Sara M.Tolaney, MD, MPH, investigators still need better methods for identifying this disease subtype to guide treatment decisions.

What we're learning is that we really need to improve our ability to detect very low levels of HER2 expression, said Tolaney. Testing will need to change so that we can potentially address all patients who are able to benefit from these therapies.

In an interview with OncLive, Tolaney, associate director of the Susan F. Smith Center for Womens Cancers; director of Clinical Trials, Breast Oncology;andsenior physician at Dana-Farber Cancer Institute, as well as anassistant professor of medicine at Harvard Medical School, discussed the challenges in treating patients with heterogenous HER2 expression and what treatments could potentially improve outcomes for this subgroup.

Tolaney: Some challenges that we face surround the patients who have heterogeneous expression for HER2. For example, it's not that the entire tumor is strongly HER2-positive. We've learned from a couple trials, 1 of them being the KRISTINE trial, and another that is exploring heterogeneity in the preoperative setting, that having heterogeneous HER2 expression can impact the efficacy of ado-trastuzumab emtansine [T-DM1; Kadcyla].

The other challenge is: What about patients who, for example, lose HER2 expression after preoperative therapy? Many of us are uncertain with what to do with those patients who have residual disease, but at the time of surgery are no longer HER2-positive. We did see some data from the KATHERINE study, which showed that even those patients who had HER2-negative disease at the time of surgery, despite being HER2-positive prior to preoperative therapy, still benefited from adjuvant T-DM1, which was quite interesting. There are all of these complexities that come up when caring for patients, but again, we're quite fortunate to have so many nice treatment options in this setting.

HER2-low is defined as tumors with a little bit of HER2 expression but aren't quite HER2-positive. What that means is that if a patient, for example, has a tumor that is 1+ by immunohistochemistry [IHC], we would consider them HER2-lowpositive. If they're HER2 2+ by IHC and is not amplified via fluorescence in situ hybridization [FISH], we would also consider them HER2-lowpositive.

We've seen from various datasets that about 55% of all breast cancers are actually HER2-low, which is a significant proportion of our patients with breast cancer. We do know that the prevalence is different by hormone receptor [HR] expression. [About 60% of] HR-positive tumors are more commonly HER2-lowpositive, as opposed to triple-negative breast cancers where only about one-third of those cases will end up being HER2-lowpositive. The prevalence is different based on breast cancer subtype.

We've seen some initial attempts looking to see if trastuzumab [Herceptin] would have any benefit in patients with a little bit of HER2 expression. We have seen data from a randomized phase 3 trial where, in fact, there was no benefit from trastuzumab added to chemotherapy in the early breast cancer setting for patients with HER2-lowpositive [disease].

What we have seen now is that some of the new ADCs do have activity in these tumors. For example, trastuzumab deruxtecan was explored in patients who were HER2-lowpositive. We saw that the objective response rates [ORRs] were almost 40% in this population; this response was similar for patients who had HER2 1+ disease compared with HER2 2+ disease; these data suggest very impressive efficacy in this subgroup.

Many of us have been a little bit perplexed about why some drugs work for HER2-lowpositive disease and others don't. For example, [when using] trastuzumab deruxtecan, we're seeing an almost 40% ORR, but we did not see significant responses with T-DM1 in subsets of HER2-lowpositive patients. Why is this? We truthfully don't have the answer, but it may be that you're delivering more chemotherapy with trastuzumab deruxtecan than you are with T-DM1. Perhaps that's why you need just a bit of HER2 expression to get that binding of the ADC and get the drug into the cancer cell.

We have also seen this with other novel ADCs, such as [vic-]trastuzumab duocarmazine [SYD985], where we've also seen ORRs between 25% and 30% in HER2-lowpositive disease. Again, this is very promising and there are lots of other drugs in development that are being studied in this setting, such as new bispecific antibodies. Were going to see many more [treatments] come in this space. There is even a registration trial ongoing with trastuzumab deruxtecan compared with standard chemotherapy for HER2-lowpositive patients.

Right now, testing for these breast cancers is really quite rudimentary and is via IHC. If a patient is HER2 1+, they would be HER2low-positive and if they are HER2 2+ but not FISH-amplified, they would be HER2low-positive. We need to see if there are better tests that can be done to detect very low levels of HER2 expression, because there may be some patients who have tumors [that dont show any positivity but have] low levels of expression that just don't quite meet criteria to be HER2 1+ that may benefit from some of these novel ADCs.

Right now, I'm very excited about the ongoing registration study for trastuzumab deruxtecan compared with physicians choice for patients who have received 1 or 2 prior chemotherapies for metastatic HER2-lowpositive breast cancer. Seeing ORRs that are near 40%, at least in the early single-arm studies, makes us quite excited about the potential to get this level of activity. This would be a nice opportunity for patients to get more personalized treatment that could improve their outcomes.

We've seen a lot of very interesting data come out about approaches to take for patients who have early-stage, HER2-positive disease. Prior to 2 or 3 years ago, we were predominantly treating patients in the adjuvant setting with HER2-directed therapy, but we have since learned that it's quite critical to give the majority of our patients preoperative therapy because we can adapt postoperative treatment to improve outcomes.

Data have evolved over the last year, and we've learned that giving adjuvant ado-trastuzumab emtansine [T-DM1; Kadcyla] can improve outcomes for patients with residual disease after neoadjuvant HER2-directed therapy.

Also, we can augment outcomes for patients by adding an additional biologic therapy, such as pertuzumab [Perjeta], to our patients who are getting chemotherapy and trastuzumab [Herceptin]. We certainly have a lot of tools added to our toolbox, but we've been trying to refine that even further. That's what the focus of a lot of the more recent developments have been on. Now that we have all of these very effective biologic therapies, can we potentially de-escalate therapy for patients who may be at lower risk? Can we potentially escalate therapy for those who may be of a higher clinical risk?

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Tolaney Touches on HER2+ -Low Breast Cancer Testing, Possibilities, and Challenges - OncLive

This article is co-authored by a patient with metastatic hormone-sensitive prostate cancer who is receiving abiraterone and androgen deprivation therapy treatment in Manchester, UK. The patient relates his personal experiences struggling with the diagnosis, his experience with treatment and the physical, emotional and psychosexual impact on his life. After his diagnosis, the patient has become an outspoken advocate and fundraiser for prostate cancer awareness and wants to ensure that novel treatments with proven efficacy and tolerability, such as abiraterone, are available for all men in his condition. The specialist nursing and physician perspectives, provided by healthcare professionals based in London who are not directly involved in this patient's care, were written in response to the challenges and concerns highlighted by this patient. The role of the specialist nurse as a key healthcare professional in the cancer patient journey, particularly in managing the complex physical and emotional side effects of treatment, is highlighted in this perspective piece. The physician reviews the current difficulties of establishing an effective screening programme in prostate cancer, the common side effects of hormone treatment and the significant progress and challenges in novel drug development and prescription in metastatic hormone-sensitive prostate cancer. While written primarily from the perspective of a patient and healthcare professionals in England, many messages in this commentary would resonate with patients and professionals involved in the care of prostate cancer worldwide.

Oncology and therapy. 2020 Oct 09 [Epub ahead of print]

Tony Collier, Shievon Smith, Michelle Greenwood, Kenrick Ng

Prostate Cancer UK, 53 Tooley Street, London, SE1 2QN, UK., St Bartholomew's Hospital, Barts Health NHS Trust, London, EC1A 7BE, UK., St Bartholomew's Hospital, Barts Health NHS Trust, London, EC1A 7BE, UK. .

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33037517

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Living with Advanced Hormone-Sensitive Prostate Cancer and Treatment with Abiraterone and Androgen Deprivation Therapy: The Patient, Nursing and...

Though COVID-19 has stopped many things this year, it hasnt stopped other life-threatening illnesses during Breast Cancer Awareness Month.

Some may be putting off an annual wellness visit or other medical procedures because they dont want to be in a medical center during the pandemic, but American Cancer Society Senior Community Development Manager Kim Durst says breast cancer and other diseases shouldnt be ignored, So if you are concerned because maybe you found a lump or its that time for you to go in and get your testing done, reach out to your healthcare provider. They are taking the precautions at the doctors offices, hospitals, and clinics where you wear your mask, use your hand sanitizer, and they are finding ways now to get people in for their checkups.

The Centers for Disease Control and Prevention states that additional ways to lower your risk of breast cancer include keeping a healthy weight and exercising regularly, limiting alcohol consumption, and asking your physician about the risk of taking hormone replacement therapy or birth control pills.

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Schedule Your Breast Cancer Screening this Month - raccoonvalleyradio.com

Olaparib (Lynparza) significantly improved overall survival (OS) versus enzalutamide (Xtandi) or abiraterone acetate (Zytiga) in patients with metastatic castration-resistant prostate cancer (mCRPC) who harbor BRCA1, BRCA2, and/or ATM aberrations, according to results from the final OS analysis of the pivotal phase 3 PROfound trial (NCT02987543).1

In the trial, patients with mCRPC who progressed on previous treatment with a new hormonal agent and harbored BRCA1, BRCA2, or ATM aberrations (n = 245; cohort A) or other alterations in the homologous recombination repair (HRR) pathway (n = 142; cohort B) were randomized 2:1 to receive either olaparib or enzalutamide or abiraterone acetate.

Final OS data from cohorts A and B were presented during the 2020 ESMO Virtual Scientific Program. Results showed that the median OS in cohort A was significantly longer with olaparib than with physicians choice (HR 0.69; 95% CI 0.50-0.97; P = .0175).1In cohort B, the median OS was 14.1 months with olaparib versus 11.5 months with the control (HR, 0.96; 95% CI, 0.63-1.49).

What is exciting about this particular trial is that it showed the feasibility of personalizing care and using precision medicine strategies to preselect patients to maximize the chance of benefit for those who are candidates for these treatments, said Maha H.A. Hussain, MD, FACP, FASCO.We can also help patients avoid unnecessary exposure to ineffective treatments.

Previously published data showed that olaparib resulted in a 66% reduction in the risk of disease progression or death compared with abiraterone or enzalutamide (HR, 0.34; 95% CI, 0.25-0.47;P<.0001).2 Based on these results, the FDA approved olaparib in May 2020 for the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR genemutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.

In an interview with OncLive, Hussain, the Genevieve E. Teuton Professor of Medicine in the Department of Medicine of the Division of Hematology Oncology and the deputy director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, further discussed the updated findings from the PROfound trial, its clinical significance in the treatment of patients with mCRPC paradigm, and the promise of precision medicine.

Hussain: PROfound is a randomized phase 3 clinical trial. It is one of the first precision medicine clinical trials to complete; patients were preselected based on specific genomic alterations and then randomized accordingly. Patients with mutations in the HRR genes or DNA damage repair genes were assigned to 2 different cohorts. The primary cohort was [comprised of] patients who had BRCA1/2 or ATM mutations, while cohort 2 included [those who harbored] other genes that are involved in the HRR pathway. Patients were randomized 2:1 to olaparib or standard of care per physicians choice of either abiraterone and prednisone or enzalutamide. The primary end point [of the trial] was radiographic progression-free survival (rPFS), which is a meaningful clinical end point, while OS was one of the several key secondary end points [examined].

Data from the Stand Up to Cancer highlighted the fact that over 20% of patients with mCRPC have significant mutations in the DNA repair pathway or the HRR genes. That [research] underscored the fact that this is a clinically relevant pathway to go after. At the time that [the PROfound trial was being designed] we saw evidence of benefit [with this approach] in other tumors [such as] breast and ovarian cancers, and then subsequently, in pancreatic cancer.

The specific pathway relevance is that both normal cells and cancer cells need to repair themselves when there is damage; the HRR pathway is involved in that repair process. However, are alterations or mutations [are present], the cells are not able to repair themselves and they fall back into a different pathway, which is the PARP pathway. Basically, PARP agents tend to inhibit that enzyme so that the [cancer] cells cannot repair themselves.

[Earlier data from the trial were previously published] this past summer. Johann de Bono, MB, ChB, PhD, of The Institute of Cancer Research was the first author on the publication in the New England Journal of Medicine, which highlighted [data regarding] the primary end point of rPFS. In this particular presentation delivered at the 2020 ESMO Virtual Congress, [investigators] reported OS [data from] cohorts A and B.

We saw that the benefit [with olaparib is] not only in terms of rPFS; the benefit translated into a median OS benefit of over 4 months between the arms, despite crossover from the control arm to the olaparib arm at time of progression. Additionally, the risk of death was reduced by 31%, which is very clinically significant. In [the cohort of patients who harbored the] other 12 genes, other than BRCA1/2 and ATM, we saw a trend in OS improvement but it was not statistically significant. The trend was about a little bit over 2 months of a difference. When adjusting for crossover, the trend improved although it was still not statistically significant. However, several patients in cohort B experienced clinical benefits from treatment. The primary benefit [with olaparib] still seems to be driven by BRCA primarily.

No; the overall safety was very much consistent with what was known about olaparib. The most common adverse effects observed included anemia, nausea, and fatigue. Most of these were low-grade events, aside from the anemia. Many of these patients were heavily pretreated; while they might have previously received abiraterone or enzalutamide, they would have also received chemotherapy and other potential anticancer treatment and be fairly advanced in the course of their disease. The findings, overall, are really not surprising and the safety profile very much consistent with what has been observed with the agent in other tumors.

We have reached a major benchmark in the management of this disease. Ever since the original observations regarding androgen deprivation [therapy] in prostate cancer and subsequent treatments, and certainly since the time I entered the field in the early 1990s, prostate cancer management has been more of a one-size-fits-all approach. In fact, when we give chemotherapy and hormone treatment we don't preselect [patients].

We still have [a lot of work to do]. Patients with metastatic castration-resistant disease continue to die from prostate cancer; they also suffer from pain and other factors involved with this disease. This [research] highlights the feasibility of performing precision medicine trials. It also shows us that meaningful clinical benefits could be achieved in these patients. I would hope that our partners across the spectrum will invest further in conducting more clinical trials.

The observation that we've seen with olaparib also opens up the door for potential combination clinical trials, both in castration-resistant disease and potentially in earlier stages of disease, where we might get a better return on investment from a clinical perspective.

Genomic profile evaluation for patients is critical moving forward, not only for the purpose of treatment for the patient. Conducting or counseling the patient regarding germline testing and tumor genomics evaluation in preparation for future treatment is also very critical. Obviously, genetic testing is associated with genetic counseling, [which may allow patients] and potential blood relatives [to get ahead of the game].

Tissue-based genomic evaluation will open the door for the patient to explore different treatments, and [certain] genomic alterations might qualify them for different clinical trials opportunities. [This work] underscores the hope for patients that their cancer can be managed better with genomically targeted treatments, specifically, in this case, the PARP inhibitor. [Now we can build on] these observations in terms of different treatment strategies and combinations.

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PROfound Trial With Olaparib Shows Feasibility of Personalizing Care in mCRPC - OncLive

NEW YORK, Oct. 12, 2020 /PRNewswire/ --Nutrafol, the award-winning hair wellness supplement backed by top physicians, celebrities and hairstylists alike, announces the positive results from its new clinical trial, an industry-first study presented on hair growth in menopausal women. The 6-month double-blind, randomized, placebo-controlled study assesses the safety and efficacy of Nutrafol's Women's Balance formulation in improving hair growth and quality in perimenopausal, menopausal and postmenopausal subjects with self-perceived thinning hair. This milestone establishes Nutrafol as the only hair supplement brand to present research specifically for menopausal women and continues to solidify Nutrafol as an innovator and trusted leader in hair science.

Forty percent of women experience hair loss by age 40, and that number continues to increase as women age.1 Nutrafol created Women's Balance - which first launched in 2019 - in response to the complex hormonal needs of women who are going through or have gone through menopause. It is the only hair wellness supplement clinically formulated to address the root causes of hair thinning in perimenopausal and menopausal women. Featuring a patented Synergen Complex Plus, it includes clinically effective natural ingredients like saw palmetto, ashwagandha and maca, known to support hormone health before, during and after menopause.

"There is unfortunately a lack of research for the physical and emotional effects that menopause has on women," said Dr. Sophia Kogan, Nutrafol's co-founder and Chief Medical Advisor. "At Nutrafol, our mission is to empower women to take control of their hair health, and hormones. After years of research, rigorous clinical testing and the accumulation of unsurpassed data, we have a proven and effective option with our Women's Balance formulation."

To assess the safety and efficacy of Women's Balance for perimenopausal, menopausal and postmenopausal women, Nutrafol conducted a 6-month randomized, double-blind, placebo-controlled trial. Results were significant for objective measures of hair growth, including terminal, vellus and total hair counts. There was a progressive increase in hair counts for Nutrafol subjects compared to placebo at three and six months. Additionally, daily administration of Nutrafol resulted in significantly less shedding compared to placebo. This was accompanied by significant visible clinical improvement in hair growth and quality in the active group, as assessed by a blinded physician investigator. Conclusively, the study verified that the daily intake of a novel supplement with bio-optimized phytoactive ingredients to specifically address multiple underlying factors that compromise hair growth was safe and effective in improving hair growth and quality in women going through menopausal transition. The Primary Investigator of the study was Dr. Glynis Ablon, MD, FAAD and founder of the Ablon Skin Institute & Research Center, an independent clinical research site specializing in dermatology clinical trials.

"Menopause is a disruptive time for women between the hormonal shifts and changes in their bodies that are out of their control," said Dr. Glynis Ablon MD, Primary Investigator on the clinical study. "Nutrafol has pioneered a new way of thinking about the science of hair wellness as it relates to menopause. With safety and efficacy at the forefront of everything the brand does, the published data supports the clinical effectiveness of the Women's Balance formulation for menopausal women. This provides physicians with a solution for their patients, and gives menopausal women the opportunity to take control of their menopausal transition and beyond."

To learn more about Nutrafol and Women's Balance, please visit http://www.Nutrafol.com or speak with your Healthcare Provider.

About NutrafolNutrafol pioneered the hair wellness category with its integrative approach to hair health, using a first-of-its-kind patented formulation of clinically effective, natural, medical-grade ingredients to support whole body wellness from within. In multiple clinical studies, Nutrafol has been shown to improve hair growth in both men and women by multi-targeting root causes of thinning hair, including stress, hormones, environment and nutrition. Nutrafol's team of doctors and researchers continue to seek out scientific advancements at the forefront of genetics, anti-aging medicine, phytoactive and biotechnology to remain on the cutting-edge of hair health innovation. Nutrafol has been adopted by over 2,700 Healthcare Providers across the U.S. for its trusted, reliable results and has received numerous prestigious accolades.

1American Academy of Dermatology

PR ContactBehrman Communications / Gianna Cesa[emailprotected] 212.986.7000

SOURCE Nutrafol

http://www.nutrafol.com

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Nutrafol Pioneers Hair Wellness Industry with New Study that Reveals it Safely and Effectively Improves Hair Growth in Menopausal Women - PRNewswire