search
Back to results

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

Primary Purpose

Precancerous Condition, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
green tea catechin extract
fish oil
placebo
placebo
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous Condition focused on measuring prostate cancer, precancerous condition

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Center for Health Research
  • OHSU Knight Cancer Institute
  • Veterans Affairs Medical Center - Portland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm I (FO, GT catechin extract)

ArmII (FO placebo, GT catechin extract)

Arm III (FO, GT placebo)

Arm IV (FO placebo, GT placebo)

Arm Description

Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day

Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day

Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day

Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2005
Last Updated
April 14, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
United States Department of Defense, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00253643
Brief Title
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Official Title
Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
United States Department of Defense, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition, Prostate Cancer
Keywords
prostate cancer, precancerous condition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (FO, GT catechin extract)
Arm Type
Experimental
Arm Description
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
Arm Title
ArmII (FO placebo, GT catechin extract)
Arm Type
Experimental
Arm Description
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Arm Title
Arm III (FO, GT placebo)
Arm Type
Experimental
Arm Description
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
Arm Title
Arm IV (FO placebo, GT placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea catechin extract
Other Intervention Name(s)
Polyphenon E
Intervention Description
Given orally 2 times/day
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Other Intervention Name(s)
omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Intervention Description
Given orally 3 times/day
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB, olive oil
Intervention Description
Given olive oil placebo orally 3 times/day
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given green tea placebo orally 2 times/day
Primary Outcome Measure Information:
Title
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
Description
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.
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)
Title
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
Description
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.
Time Frame
End of study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, PhD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27646578
Citation
Zhang Z, Garzotto M, Beer TM, Thuillier P, Lieberman S, Mori M, Stoller WA, Farris PE, Shannon J. Effects of omega-3 Fatty Acids and Catechins on Fatty Acid Synthase in the Prostate: A Randomized Controlled Trial. Nutr Cancer. 2016 Nov-Dec;68(8):1309-1319. doi: 10.1080/01635581.2016.1224365. Epub 2016 Sep 20.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs