Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
- 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 a randomized, double-blind, placebo-controlled study. Patients are
stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4
- Arm I: Patients receive oral fish oil three times daily and oral green tea extract
- Arm II: Patients receive an oil placebo three times daily and oral green tea extract
- Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
- Arm IV: Patients receive an oil placebo three times daily and another placebo twice
Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of
disease progression or unacceptable toxicity.
All patients undergo a prostate biopsy on the last day of study treatment.
After completion of study treatment, patients receive a follow-up phone call at/around 30
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention
End of study
Jackilen Shannon, PhD
OHSU Knight Cancer Institute
United States: Federal Government
|Kaiser Permanente Center for Health Research||Portland, Oregon 97227-1098|
|Veterans Affairs Medical Center - Portland||Portland, Oregon 97207|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|