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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00253643
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : February 18, 2015
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jackie Shannon, OHSU Knight Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Precancerous Condition Prostate Cancer Dietary Supplement: green tea catechin extract Dietary Supplement: fish oil Other: placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2005
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Fish oil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (FO, GT catechin extract)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
 Dietary Supplement: green tea catechin extract
Given orally 2 times/day
Other Name: Polyphenon E

Dietary Supplement: fish oil
Given orally 3 times/day
Other Name: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Experimental: ArmII (FO placebo, GT catechin extract)
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
 Dietary Supplement: green tea catechin extract
Given orally 2 times/day
Other Name: Polyphenon E

Other: placebo
Given green tea placebo orally 2 times/day
Other Name: PLCB
Experimental: Arm III (FO, GT placebo)
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
 Dietary Supplement: fish oil
Given orally 3 times/day
Other Name: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA

Other: placebo
Given olive oil placebo orally 3 times/day
Other Name: PLCB, olive oil
Placebo Comparator: Arm IV (FO placebo, GT placebo)
Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day
 Other: placebo
Given olive oil placebo orally 3 times/day
Other Name: PLCB, olive oil

Other: placebo
Given green tea placebo orally 2 times/day
Other Name: PLCB


Outcome Measures
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Primary Outcome Measures :
  1. Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) [ Time Frame: 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) ]
    Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.

  2. Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention [ Time Frame: End of study ]
    Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253643


Locations
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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
United States Department of Defense
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00253643    
Other Study ID Numbers: CDR0000443617
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-CI-CPC-04131-LX ( Other Identifier: OHSU Knight Cancer Institute number )
VAMC-04-0303/ M1016 ( Other Identifier: Portland VA IRB number )
DOD-W81XWH-04-1-0296 ( Other Grant/Funding Number: Dept of Defense Award Number )
OHSU-1117 ( Other Identifier: OHSU IRB number )
KPNW-NW-05SLIEB-01 ( Other Identifier: Kaiser Permanente NW IRB number )
First Posted: November 15, 2005    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Jackie Shannon, OHSU Knight Cancer Institute:
prostate cancer
precancerous condition
Additional relevant MeSH terms:
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Prostatic Neoplasms
Precancerous Conditions
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Epigallocatechin gallate
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents