NCT00253643

Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 21 Years – 120 Years
• Healthy volunteers: Accepted

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.

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 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 treatment arms. * Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily. * Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily. * 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 daily. 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 days later. PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.

Conditions

• Precancerous Condition
• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	green tea catechin extract	Given orally 2 times/day
DIETARY_SUPPLEMENT	fish oil	Given orally 3 times/day
OTHER	placebo	Given olive oil placebo orally 3 times/day
OTHER	placebo	Given green tea placebo orally 2 times/day

Timeline

• Start date: 2005-07-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2005-11-15
• Last updated: 2017-04-18
• Results posted: 2015-02-18

Locations

3 sites across 1 country: United States