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Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253643 |
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 |
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Precancerous/Nonmalignant Condition Prostate Cancer |
Drug: green tea extract Drug: omega-3 fatty acids Drug: placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial |
Estimated Enrollment: | 144 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral fish oil three times daily and oral green tea extract twice daily.
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Drug: green tea extract
Given orally
Drug: omega-3 fatty acids
Given orally
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Arm II: Experimental
Patients receive a placebo three times daily and oral green tea extract twice daily.
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Drug: green tea extract
Given orally
Drug: placebo
Given orally
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Arm III: Experimental
Patients receive oral fish oil three times daily and a placebo twice daily
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Drug: omega-3 fatty acids
Given orally
Drug: placebo
Given orally
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Arm IV: Placebo Comparator
Patients receive one placebo three times daily and another placebo twice daily.
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Drug: placebo
Given orally
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OBJECTIVES:
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.
Treatment in both 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 are followed for 30 days.
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No definitive prostate cancer on initial biopsy
PATIENT CHARACTERISTICS:
Hematopoietic
Hepatic
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Oregon | |
Kaiser Permanente Center for Health Research | Recruiting |
Portland, Oregon, United States, 97227 | |
Contact: Courtney Maxcy 503-220-8262 ext 54931 | |
Oregon Health and Science University Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu | |
Veterans Affairs Medical Center - Portland | Recruiting |
Portland, Oregon, United States, 97234 | |
Contact: Courtney Maxcy 503-220-8262 ext. 54931 |
Principal Investigator: | Jackilen Shannon, PhD | Oregon Health and Science University Cancer Institute |
Study ID Numbers: | CDR0000443617, OHSU-CI-CPC-04131-LX, VAMC-04-0303, DOD-A-12538, OHSU-1117, OHSU-KPNW-NW-05SLIEB-01 |
Study First Received: | November 11, 2005 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00253643 |
Health Authority: | Unspecified |
prostate cancer precancerous/nonmalignant condition |
Prostatic Diseases Genital Neoplasms, Male Precancerous Conditions |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |