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Grape Seed Extract

Estrogens

Aromatase Inhibitors

Antioxidants

Protective Agents

Grape

Dietlind L. Wahner-Roedler, M.D.

The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.

Early detection of breast cancer with screening mammography and the use of more effective medical therapies have led to a decrease in breast cancer mortality. However, breast cancer is still the second leading cause of cancer death in women (2). Therefore, the future lies in not only early detection but prevention of breast cancer. Currently available chemopreventive agents are associated with potentially serious side effects and can be quite costly, especially when taken for extended periods of time. Therefore, they are usually targeted only to women at high risk of disease. Identification of an inexpensive, efficacious preventive therapy with few or no side effects would represent a major advance in reducing the morbidity and mortality due to breast cancer. One exciting possibility is grape seed extract. Grapes and grape seeds contain procyanidins, a highly active subclass of flavonoids with actions similar to pharmaceutical aromatase inhibitors (AIs). These procyanidin dimers have been found to suppress estrogen biosynthesis both in vitro and in animal models (1). Based upon this knowledge we proposed this dose finding pilot study.

The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women

The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study

Mayo Clinic

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation.

Patients will take 150 mg of Grape Seed Extract (GSE) product by mouth twice daily (in the form of 75 mg capsule of Leucoselect Phytosome preparation). Total oral dosage is 300 mg of GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits.

Paul Maroni, MD

Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year.

Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits and patients must not have a doubling of their PSA (compared to baseline) by 3 months in order to continue on study. Patients who meet criteria to continue on study will be treated until disease progression or for one year (whichever comes first).

A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA

A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)

PSA response will be defined as an increase in prostate specific antigen (PSA) doubling time (PSADT) of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Patients must have a PSA level of ≥ 0.2 at study entry and should have at least three prior PSA values with dates from which to calculate a PSA doubling time.

PSA velocity will be calculated as a change from the first PSA reading, standardized as PSA change per month. PSA Response will be defined as increase in PSADT of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Biomarkers will be defined as proinflammatory cytokines, lipid and comprehensive metabolic panel in patient serum samples as well as, gut microbiome (measured by by high-throughput16S sequencing), plasma and stool metabolomics (after short and long-term consumption of GSE), and the effects of diet on gut microbiome.

University of Colorado, Denver

Micronutrients

Bone Density Conservation Agents

Anti-Inflammatory Agents

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Vitamin D3

Calciferol

All patients will take Grape Seed Extract from Day 1 to Day 21. All patients will take Grape Seed Extract and Vitamin D together from Day 22 until Day 64. For all patients on the study, patients will take Vitamin D once a day at a dose of 4000IU.

All patients enrolled to the study will take Grape Seed Extract alone for 21 days.

From Day 22 until Day 64 of the study, patients will take Grape Seed Extract and Vitamin D together. Patients will take Vitamin D once at a day at 4000 IU.

Michael Lilly, MD

This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer.

This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract (GSE). Researchers are in looking at the combination of GSE and vitamin D in subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). Researchers will examine the safety of the GSE and vitamin D when GSE is given at different doses. Researchers will also look at the effects of GSE and vitamin D on your quality of life and your body. In particular, they will look at differences in biomarkers in your blood and urine.

Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer

Other markers that will be measured will include serum CRP, albumin, AGEs (advanced glycation end products), rAGE (soluble receptor for AGEs), 25-OH-vitamin D3, and urine for oxidative damage DNA biomarkers (urinary 8-oxoGua and 8-oxodG). Correlations between dose and change in these parameters from before to 21, 63 days after start of GSE dosing will be described.

Serial QOL assessments will be made by the FACT series of QOL questionnaires

The ability of a fixed dose of vitamin D3 (4000 IU daily) to further suppress IL-6 levels in subjects on GSE treatment will be evaluated.

Decisions to escalate or expand a dose level will be based only on the GSE-only treatment period (day 1-21). To be evaluable for toxicity, a patient must receive at least 3 weeks of GSE treatment, or have experienced dose-limiting toxicity (DLT). All patients enrolled are to be fully followed for toxicity, but any patients who are not evaluable for toxicity will be replaced.

Plasma IL-6 levels before and after 21 days and 63 days of GSE treatment will be quantified to estimate the dose response relationship between GSE dose and reduction in inflammation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women	NCT00566553	Breast Cancer	Grape Seed Extr... Grape Seed Extr... Grape Seed Extr... Grape Seed Extr...	55 Years - 75 Years	Mayo Clinic
A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA	NCT03087903	Prostate Cancer	Grape Seed Extr...	18 Years - 99 Years	University of Colorado, Denver
Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer	NCT01820299	Solid Cancers	Grape Seed Extr... Vitamin D	18 Years -	Medical University of South Carolina
Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer	NCT01820299	Solid Cancers	Grape Seed Extr... Vitamin D	18 Years -	Medical University of South Carolina
A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA	NCT03087903	Prostate Cancer	Grape Seed Extr...	18 Years - 99 Years	University of Colorado, Denver

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