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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00253643
First received: November 11, 2005
Last updated: February 13, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Precancerous Condition
Prostate Cancer
Dietary Supplement: green tea catechin extract
Dietary Supplement: fish oil
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of study ] [ Designated as safety issue: No ]
    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.


Enrollment: 89
Study Start Date: July 2005
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Polyphenon E
Dietary Supplement: fish oil
Given orally 3 times/day
Other Name: 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 Name: Polyphenon E
Other: placebo
Given green tea placebo orally 2 times/day
Other Name: 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 Name: 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 Name: PLCB, olive oil
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 Name: PLCB, olive oil
Other: placebo
Given green tea placebo orally 2 times/day
Other Name: PLCB

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253643

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00253643     History of Changes
Other Study ID Numbers: CDR0000443617, P30CA069533, OHSU-CI-CPC-04131-LX, VAMC-04-0303/ M1016, DOD-W81XWH-04-1-0296, OHSU-1117, KPNW-NW-05SLIEB-01
Study First Received: November 11, 2005
Results First Received: December 19, 2014
Last Updated: February 13, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
prostate cancer
precancerous condition

Additional relevant MeSH terms:
Precancerous Conditions
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 26, 2015