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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00253643
First received: November 11, 2005
Last updated: December 7, 2012
Last verified: December 2012
  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: defined green tea catechin extract
Dietary Supplement: omega-3 fatty acid
Other: placebo
Other: laboratory biomarker analysis
Other: questionnaire administration

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:


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 Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (fish oil, green tea extract)
Patients receive oral fish oil three times daily and oral green tea extract twice daily.
Dietary Supplement: defined green tea catechin extract
Given orally
Other Name: Polyphenon E
Dietary Supplement: omega-3 fatty acid
Given orally
Other Name: fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (fish oil placebo, green tea extract)
Patients receive an oil placebo three times daily and oral green tea extract twice daily.
Dietary Supplement: defined green tea catechin extract
Given orally
Other Name: Polyphenon E
Other: placebo
Given fish oil placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm III (fish oil, green tea extract placebo)
Patients receive oral fish oil three times daily and a placebo twice daily
Dietary Supplement: omega-3 fatty acid
Given orally
Other Name: fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Other: placebo
Given green tea extract placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Placebo Comparator: Arm IV (fish oil placebo, green tea extract placebo)
Patients receive an oil placebo three times daily and another placebo twice daily.
Other: placebo
Given fish oil placebo orally
Other Name: PLCB
Other: placebo
Given green tea extract placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies

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:   21 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
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
  More Information

Additional Information:
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: December 7, 2012
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:
Precancerous Conditions
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014