Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
21 Years
N/A
Male
Precancerous Condition, Prostate Cancer
Trial Information
Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention
Outcome Time Frame:
End of study
Safety Issue:
No
Principal Investigator
Jackilen Shannon, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000443617
NCT ID:
NCT00253643
Start Date:
July 2005
Completion Date:
September 2013
Related Keywords:
- Precancerous Condition
- Prostate Cancer
- prostate cancer
- precancerous condition
- Precancerous Conditions
- Prostatic Neoplasms
Name | Location |
|---|---|
| Kaiser Permanente Center for Health Research | Portland, Oregon 97227-1098 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
