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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 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 106 participants.

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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.

Interventions

  • OTHER Placebo
  • OTHER ADT
  • DRUG MGE

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2019-01-29
Est. Completion 2025-08-14
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT03496805

The ClinicalTrials.gov registry entry for NCT03496805 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03496805 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.