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

Not Applicable

Completed

• Conditions: Precancerous Condition; Prostate Cancer
• Interventions: Dietary Supplement: green tea catechin extract; Other: placebo; Dietary Supplement: fish oil

• Registration Number: NCT00253643
• Lead Sponsor: OHSU Knight Cancer Institute

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 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Results First Submitted: 2014-12-19
• Results First Submitted QC: 2015-02-13
• Results First Posted: 2015-02-18
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ArmII (FO placebo, GT catechin extract)	placebo	Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Arm IV (FO placebo, GT placebo)	placebo	Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day
Arm I (FO, GT catechin extract)	green tea catechin extract	Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
Arm I (FO, GT catechin extract)	fish oil	Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
ArmII (FO placebo, GT catechin extract)	green tea catechin extract	Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Arm III (FO, GT placebo)	fish oil	Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
Arm III (FO, GT placebo)	placebo	Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day

Primary Outcome Measures

Name	Time	Method
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)	Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)	Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention	End of study	Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.

Trial Locations

Locations (3)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Kaiser Permanente Center for Health Research; 🇺🇸 Portland, Oregon, United States

Veterans Affairs Medical Center - Portland; 🇺🇸 Portland, Oregon, United States