Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
NCT ID: NCT00253643
Last Updated: 2017-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2005-07-31
2013-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (FO, GT catechin extract)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
green tea catechin extract
Given orally 2 times/day
fish oil
Given orally 3 times/day
ArmII (FO placebo, GT catechin extract)
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
green tea catechin extract
Given orally 2 times/day
placebo
Given green tea placebo orally 2 times/day
Arm III (FO, GT placebo)
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
fish oil
Given orally 3 times/day
placebo
Given olive oil placebo orally 3 times/day
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
placebo
Given olive oil placebo orally 3 times/day
placebo
Given green tea placebo orally 2 times/day
Interventions
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green tea catechin extract
Given orally 2 times/day
fish oil
Given orally 3 times/day
placebo
Given olive oil placebo orally 3 times/day
placebo
Given green tea placebo orally 2 times/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
120 Years
MALE
Yes
Sponsors
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United States Department of Defense
FED
National Cancer Institute (NCI)
NIH
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Jackie Shannon
Principal Investigator
Principal Investigators
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Jackilen Shannon, PhD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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Kaiser Permanente Center for Health Research
Portland, Oregon, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
Countries
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References
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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.
Other Identifiers
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OHSU-CI-CPC-04131-LX
Identifier Type: OTHER
Identifier Source: secondary_id
VAMC-04-0303/ M1016
Identifier Type: OTHER
Identifier Source: secondary_id
DOD-W81XWH-04-1-0296
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OHSU-1117
Identifier Type: OTHER
Identifier Source: secondary_id
KPNW-NW-05SLIEB-01
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000443617
Identifier Type: -
Identifier Source: org_study_id
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