Status:
COMPLETED
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
United States Department of Defense
National Cancer Institute (NCI)
Conditions:
Precancerous Condition
Prostate Cancer
Eligibility:
MALE
21-120 years
Phase:
NA
Brief 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...
Detailed Description
OBJECTIVES: * Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples. OUTLINE: This is ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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)
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00253643
Start Date
July 1 2005
End Date
December 1 2013
Last Update
April 18 2017
Active Locations (3)
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1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
3
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97239