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NCT03496805 · ClinicalTrials.gov registry record · Phase 2
Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT03496805: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT03496805 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496805, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study 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.
Primary Outcome
The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: \<50 normal; 50-59 mild; 60-69 moderate; ≥70 severe. 50 indicates the population mean with a standard deviation of 10
Interventions
- OTHER Placebo
- OTHER ADT
- DRUG MGE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2025-08-14 |
| Phase | Phase 2 |
What the finished NCT03496805 record still lists
NCT03496805 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03496805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496805 about?
NCT03496805 is a clinical study titled "Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy". 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 implementa...
What is the current status of trial NCT03496805?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2019-01-29. Estimated completion is 2025-08-14.
What interventions are being tested in trial NCT03496805?
The interventions under investigation include: Placebo (OTHER), ADT (OTHER), MGE (DRUG).
Who is sponsoring clinical trial NCT03496805?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03496805's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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