Clinical trial NCT00253643: Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Official title: Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Condition
Prostate Cancer
Keywords: prostate cancer
precancerous condition
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: National Cancer Institute (NCI)
First posted: 2005-11-15
Enrollment: 89
Sex: MALE
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
timeFrame: Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)
measure: Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Veterans Affairs Medical Center - Portland
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Jackilen Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Z, Garzotto M, Beer TM, Thuillier P, Lieberman S, Mori M, Stoller WA, Farris PE, Shannon J. Effects of omega-3 Fatty Acids and Catechins on Fatty Acid Synthase in the Prostate: A Randomized Controlled Trial. Nutr Cancer. 2016 Nov-Dec;68(8):1309-1319. doi: 10.1080/01635581.2016.1224365. Epub 2016 Sep 20.