Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03496805
Brief 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.
Study:
NCT03496805
Study Brief:
Protocol Section:
NCT03496805