At a glance
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A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
In Brief
A Phase 2 clinical trial evaluating MGE, Placebo, and 1 other intervention for Recurrent Prostate Cancer. Completed, enrolled 106 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
The patients will take 4 capsules by mouth BID (twice daily).
The patients will take 4 capsules by mouth BID (twice daily).
Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.