CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
green tea catechin extract +3 moredietary
Likely dose
Green tea catechin extract orally 2 times/day; fish oil orally 3 times/dayAI-extracted
Key inclusion· 1
  • Clinician recommends repeat prostate biopsy (any biopsy subsequent to an earlier prostate biopsy)
Key exclusion· 8
  • Definitive invasive prostate cancer on initial biopsy
  • Significant active medical illness that would preclude protocol treatment per clinician judgment
  • History of ventricular tachycardia or ventricular fibrillation
  • Use of warfarin or need for therapeutic anticoagulation at time of biopsy or during trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00253643
NCT00253643N/ACompleted

Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial

OHSU Knight Cancer Institute·interventional·Posted Nov 15, 2005·Updated Apr 18, 2017

In Brief

A clinical study evaluating green tea catechin extract, fish oil, and 1 other intervention for Precancerous Condition and Prostate Cancer. Completed, enrolled 89 participants across 3 sites.

Detailed Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer. PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartJul 1, 2005
Primary CompletionSep 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 20.6 years ago

Interventions

green tea catechin extractdietary

Given orally 2 times/day

fish oildietary

Given orally 3 times/day

placeboother

Given olive oil placebo orally 3 times/day

placeboother

Given green tea placebo orally 2 times/day