Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Completed · Not applicable · Has a placebo group
Conditions studied: Precancerous Condition, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00253643
- Run by
- OHSU Knight Cancer Institute
- People needed
- 89
- Starts
- 2005-07-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-04-18
Who can join
Age: 21 and older, up to 120. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)
You may not qualify if…
- Definitive invasive prostate cancer on initial biopsy
- Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
- History of ventricular tachycardia or ventricular fibrillation
- Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
- Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
- Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.
- Subject reported allergy or sensitivity to fish oil, olive oil or green tea
- Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
- Total bilirubin greater than institutional upper limit of normal
- Concurrent high risk study participation
Where it is running
- Kaiser Permanente Center for Health Research — Portland, Oregon, United States
- OHSU Knight Cancer Institute — Portland, Oregon, United States
- Veterans Affairs Medical Center - Portland — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.