NCT03496805

Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months. Secondary Objectives * To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months. * To compare quality of life in men in the MGE group compared to the placebo group. * To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group. * To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group. * To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group. OUTLINE: Participants are randomized into 1 of 2 groups. GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity. GROUP II (PLACEBO): Participants begin Androgen deprivation therapy prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 72 hours and then for up to 12 months.

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	MGE	The patients will take 4 capsules by mouth BID (twice daily).
OTHER	Placebo	The patients will take 4 capsules by mouth BID (twice daily).
OTHER	ADT	Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.

Timeline

• Start date: 2019-01-29
• Primary completion: 2025-02-20
• Completion: 2025-08-14
• First posted: 2018-04-12
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study