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Clinical Trial Summary

It is estimated that one-third of the more than 7 million deaths from cancer worldwide are attributable to potentially modifiable risk factors, with 374,000 deaths preventable through diet modification alone. Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also suggests that muscadine grape products may decrease systemic inflammation. This study builds upon promising preclinical and clinical evidence to determine if the addition muscadine grape extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate cancer.


Clinical Trial Description

Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. The muscadine grape contains a high concentration of anthocyanin 3,5-diglucosides, ellagic acid, ellagic acid precursors, gallic acid, flavan-3-ols and flavonols. Several preclinical studies with muscadine grape products have revealed anti-tumor activity, including inhibition of tumor cell growth and induction of apoptosis. By reducing levels of circulating inflammatory markers such as CRP and IL-6, muscadine grape products may improve cancer outcomes by decreasing symptom burden, particularly fatigue. Despite reports indicating potential anti-tumor activity, there are limited clinical studies on the efficacy of muscadine grape products in the prevention or treatment of cancer or cancer-related side effects, representing an opportunity for novel investigation. The primary goal will be to determine whether treatment with MGE can improve measures of fatigue in men with biochemically recurrent prostate cancer on androgen deprivation therapy (ADT). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03496805
Study type Interventional
Source Wake Forest University Health Sciences
Contact Katherine Pleasant
Phone 3367135045
Email kpleasan@wakehealth.edu
Status Not yet recruiting
Phase Phase 2
Start date August 2018
Completion date June 2021

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