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

April 14, 2017 updated by: Jackie Shannon, OHSU Knight Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
      • Portland, Oregon, United States, 97239-3098
        • OHSU Knight Cancer Institute
      • Portland, Oregon, United States, 97239
        • Veterans Affairs Medical Center - Portland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (FO, GT catechin extract)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
Dietary supplement: green tea catechin extract
Given orally 2 times/day
Other Names:
  • Polyphenon E
Dietary supplement: fish oil
Given orally 3 times/day
Other Names:
  • omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Experimental: ArmII (FO placebo, GT catechin extract)
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Dietary supplement: green tea catechin extract
Given orally 2 times/day
Other Names:
  • Polyphenon E
Other: placebo
Given olive oil placebo orally 3 times/day
Other Names:
  • PLCB, olive oil
Other: placebo
Given green tea placebo orally 2 times/day
Other Names:
  • PLCB
Experimental: Arm III (FO, GT placebo)
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
Dietary supplement: fish oil
Given orally 3 times/day
Other Names:
  • omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Other: placebo
Given olive oil placebo orally 3 times/day
Other Names:
  • PLCB, olive oil
Other: placebo
Given green tea placebo orally 2 times/day
Other Names:
  • PLCB
Placebo Comparator: Arm IV (FO placebo, GT placebo)
Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day
Other: placebo
Given olive oil placebo orally 3 times/day
Other Names:
  • PLCB, olive oil
Other: placebo
Given green tea placebo orally 2 times/day
Other Names:
  • PLCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
Time Frame: 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.
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)
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
Time Frame: 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.
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)
United States Department of Defense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000443617
  • P30CA069533 (U.S. NIH Grant/Contract)
  • OHSU-CI-CPC-04131-LX (Other Identifier: OHSU Knight Cancer Institute number)
  • VAMC-04-0303/ M1016 (Other Identifier: Portland VA IRB number)
  • DOD-W81XWH-04-1-0296 (Other Grant/Funding Number: Dept of Defense Award Number)
  • OHSU-1117 (Other Identifier: OHSU IRB number)
  • KPNW-NW-05SLIEB-01 (Other Identifier: Kaiser Permanente NW IRB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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