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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Fish oil

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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
Placebo Comparator: Arm IV Patients receive an oil 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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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

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

Sponsors and Collaborators

OHSU Knight Cancer Institute

Department of Defense

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

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

Keywords provided by OHSU Knight Cancer Institute:

prostate cancer
precancerous condition

Additional relevant MeSH terms:

Disease
Precancerous Conditions
Prostatic Neoplasms
Pathologic Processes
Neoplasms

Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012