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Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial


N/A
21 Years
N/A
Open (Enrolling)
Male
Precancerous Condition, Prostate Cancer

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Trial Information

Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention

Outcome Time Frame:

End of study

Safety Issue:

No

Principal Investigator

Jackilen Shannon, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000443617

NCT ID:

NCT00253643

Start Date:

July 2005

Completion Date:

September 2013

Related Keywords:

  • Precancerous Condition
  • Prostate Cancer
  • prostate cancer
  • precancerous condition
  • Precancerous Conditions
  • Prostatic Neoplasms

Name

Location

Kaiser Permanente Center for Health ResearchPortland, Oregon  97227-1098
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
OHSU Knight Cancer InstitutePortland, Oregon  97239