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

OHSU Knight Cancer Institute

Status: Completed

Conditions: Precancerous Condition; Prostate Cancer

Treatments: Other: placebo; Dietary Supplement: green tea catechin extract; Dietary Supplement: fish oil

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00253643

DOD-W81XWH-04-1-0296 (Other Grant/Funding Number)

OHSU-1117 (Other Identifier)

CDR0000443617

OHSU-CI-CPC-04131-LX (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

KPNW-NW-05SLIEB-01 (Other Identifier)

VAMC-04-0303/ M1016 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: Male

Ages: 21 to 120 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

89 participants in 4 patient groups, including a placebo group

Arm I (FO, GT catechin extract)

Experimental group

Description:

Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day

Treatment:

Dietary Supplement: fish oil

Dietary Supplement: green tea catechin extract

ArmII (FO placebo, GT catechin extract)

Experimental group

Description:

Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day

Treatment:

Other: placebo

Dietary Supplement: green tea catechin extract

Other: placebo

Arm III (FO, GT placebo)

Experimental group

Description:

Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day

Treatment:

Dietary Supplement: fish oil

Other: placebo

Other: placebo

Arm IV (FO placebo, GT placebo)

Placebo Comparator group

Description:

Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day

Treatment:

Other: placebo

Other: placebo