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| Sponsor: | OHSU Knight Cancer Institute |
|---|---|
| Collaborators: |
Department of Defense National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00253643 |
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 extract Dietary Supplement: omega-3 fatty acid Other: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
| Estimated Enrollment: | 144 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral fish oil three times daily and oral green tea extract twice daily.
|
Dietary Supplement: green tea extract
Given orally
Dietary Supplement: omega-3 fatty acid
Given orally
|
|
Experimental: Arm II
Patients receive an oil placebo three times daily and oral green tea extract twice daily.
|
Dietary Supplement: green tea extract
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm III
Patients receive oral fish oil three times daily and a placebo twice daily
|
Dietary Supplement: omega-3 fatty acid
Given orally
Other: placebo
Given orally
|
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Placebo Comparator: Arm IV
Patients receive an oil placebo three times daily and another placebo twice daily.
|
Other: placebo
Given orally
|
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 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: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations| United States, Oregon | |
| Kaiser Permanente Center for Health Research | |
| Portland, Oregon, United States, 97227 | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jackilen Shannon, PhD | OHSU Knight Cancer Institute |
More Information
| 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 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
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prostate cancer precancerous condition |
|
Disease Precancerous Conditions Prostatic Neoplasms Pathologic Processes Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |