Overview

This trial is active, not recruiting.

Conditions precancerous condition, prostate cancer
Treatments defined green tea catechin extract, omega-3 fatty acid, placebo, laboratory biomarker analysis, questionnaire administration
Sponsor OHSU Knight Cancer Institute
Collaborator Department of Defense
Start date July 2005
End date September 2012
Trial size 144 participants
Trial identifier NCT00253643, CDR0000443617, DOD-W81XWH-04-1-0296, KPNW-NW-05SLIEB-01, OHSU-1117, OHSU-CI-CPC-04131-LX, P30CA069533, VAMC-04-0303/ M1016

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Patients receive oral fish oil three times daily and oral green tea extract twice daily.
defined green tea catechin extract Polyphenon E
Given orally
omega-3 fatty acid fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Given orally
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
(Experimental)
Patients receive an oil placebo three times daily and oral green tea extract twice daily.
defined green tea catechin extract Polyphenon E
Given orally
placebo PLCB
Given fish oil placebo orally
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
(Experimental)
Patients receive oral fish oil three times daily and a placebo twice daily
omega-3 fatty acid fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Given orally
placebo PLCB
Given green tea extract placebo orally
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
(Placebo Comparator)
Patients receive an oil placebo three times daily and another placebo twice daily.
placebo PLCB
Given fish oil placebo orally
placebo PLCB
Given green tea extract placebo orally
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention
time frame: End of study
Cell proliferation by Ki67-immunohistochemistry at pre- and post-intervention
time frame: End of study
Phospholipid membrane composition by sucrose gradient ultracentrifugation at post-intervention
time frame: End of study
Comparison of the synergistic effect of combined green tea and fish oil to placebo or green tea supplementation alone
time frame: End of study

Secondary Outcomes

Measure
Sterol regulatory element binding protein expression by immunohistochemistry at pre- and post-intervention
time frame: End of study
Apoptosis as measured by TUNEL at pre- and post-intervention
time frame: End of study
Bone formation and loss by serum and urine osteocalcin and N-telopeptides at pre- and post-intervention
time frame: End of study

Eligibility Criteria

Male participants at least 21 years old.

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

Additional Information

Official title Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
Principal investigator Jackilen Shannon, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by OHSU Knight Cancer Institute.