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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253643
• Other study ID #: CDR0000443617
• Secondary ID: P30CA069533OHSU-
• Status: Completed
• Phase: N/A
• First received: November 11, 2005
• Last updated: April 14, 2017
• Start date: July 2005
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Precancerous Condition
• Precancerous Conditions
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• green tea catechin extract
Given orally 2 times/day
• fish oil
Given orally 3 times/day

Other:
• placebo
Given olive oil placebo orally 3 times/day
• placebo
Given green tea placebo orally 2 times/day

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)	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.	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)
Primary	Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention	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.	End of study