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

Sponsor:	Oregon Health and Science University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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/Nonmalignant Condition Prostate Cancer	Dietary Supplement: green tea extract Dietary Supplement: omega-3 fatty acids Other: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention [ Designated as safety issue: No ]
Cell proliferation by Ki67-immunohistochemistry at pre- and post-intervention [ Designated as safety issue: No ]
Phospholipid membrane composition by sucrose gradient ultracentrifugation at post-intervention [ Designated as safety issue: No ]
Comparison of the synergistic effect of combined green tea and fish oil to placebo or green tea supplementation alone [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sterol regulatory element binding protein expression by immunohistochemistry at pre- and post-intervention [ Designated as safety issue: No ]
Apoptosis as measured by TUNEL at pre- and post-intervention [ Designated as safety issue: No ]
Bone formation and loss by serum and urine osteocalcin and N-telopeptides at pre- and post-intervention [ Designated as safety issue: No ]

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
Arm I: Experimental 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 acids Given orally
Arm II: Experimental Patients receive a placebo three times daily and oral green tea extract twice daily.	Dietary Supplement: green tea extract Given orally Other: placebo Given orally
Arm III: Experimental Patients receive oral fish oil three times daily and a placebo twice daily	Dietary Supplement: omega-3 fatty acids Given orally Other: placebo Given orally
Arm IV: Placebo Comparator Patients receive one placebo three times daily and another placebo twice daily.	Other: placebo Given orally

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 a 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 one placebo three times daily and another placebo twice daily.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

No definitive prostate cancer on initial biopsy
- Patients may receive a repeat biopsy of the prostate

PATIENT CHARACTERISTICS:

Hematopoietic

No hemophilia or von Willebrand's disease (patient-reported)
No other bleeding disorder (patient-reported)

Hepatic

Total bilirubin normal

Cardiovascular

No implantable cardioverter defibrillator with episodes of ventricular tachycardia or ventricular fibrillation within the past 3 months

Other

No known allergy or sensitivity to fish oil, olive oil, or green tea
No significant active medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

No concurrent chemotherapy for prostate cancer

Endocrine therapy

No concurrent hormonal therapy for prostate cancer

Radiotherapy

No concurrent radiotherapy for prostate cancer

Surgery

No concurrent surgery for prostate cancer

Other

More than 30 days since prior and no concurrent use of or prescription for fish oil or green tea supplement
No concurrent warfarin, therapeutic anticoagulation, or other blood-thinning agents
No concurrent treatment for prostate or other nonskin cancer
No concurrent participation in another moderate to high-risk study

Contacts and Locations

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

Locations

United States, Oregon
Kaiser Permanente Center for Health Research	Recruiting
Portland, Oregon, United States, 97227
Contact: Courtney Maxcy 503-220-8262 ext 54931
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu
Veterans Affairs Medical Center - Portland	Recruiting
Portland, Oregon, United States, 97239
Contact: Courtney Maxcy 503-220-8262 ext. 54931

Sponsors and Collaborators

Oregon Health and Science University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jackilen Shannon, PhD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	June 25, 2009
ClinicalTrials.gov Identifier:	NCT00253643 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

prostate cancer
precancerous/nonmalignant condition

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Precancerous Conditions
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009