NCT00253643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 18, 2015

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

8.2 years

First QC Date

November 11, 2005

Results QC Date

December 19, 2014

Last Update Submit

April 14, 2017

Conditions

Precancerous ConditionProstate Cancer

Keywords

prostate cancerprecancerous condition

Outcome Measures

Primary Outcomes (2)

  • Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)

    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.

    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)

  • Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention

    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.

    End of study

Study Arms (4)

Arm I (FO, GT catechin extract)

EXPERIMENTAL

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

Dietary Supplement: green tea catechin extractDietary Supplement: fish oil

ArmII (FO placebo, GT catechin extract)

EXPERIMENTAL

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

Dietary Supplement: green tea catechin extractOther: placebo

Arm III (FO, GT placebo)

EXPERIMENTAL

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

Dietary Supplement: fish oilOther: placebo

Arm IV (FO placebo, GT placebo)

PLACEBO COMPARATOR

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

Other: placebo

Interventions

green tea catechin extractDIETARY_SUPPLEMENT

Given orally 2 times/day

Also known as: Polyphenon E
Arm I (FO, GT catechin extract)ArmII (FO placebo, GT catechin extract)
fish oilDIETARY_SUPPLEMENT

Given orally 3 times/day

Also known as: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Arm I (FO, GT catechin extract)Arm III (FO, GT placebo)
placeboOTHER

Given olive oil placebo orally 3 times/day

Also known as: PLCB, olive oil
Arm III (FO, GT placebo)Arm IV (FO placebo, GT placebo)

Eligibility Criteria

Age21 Years - 120 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 27646578DERIVED

MeSH Terms

Conditions

Precancerous ConditionsProstatic Neoplasms

Interventions

polyphenon EFish OilsFatty Acids, Omega-3Docosahexaenoic AcidsOlive Oil

Condition Hierarchy (Ancestors)

NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFatty Acids, UnsaturatedFatty AcidsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Jackilen Shannon
Organization
Oregon Health & Science University
shannoja@ohsu.edu
503-220-8262

Study Officials

  • Jackilen Shannon, PhD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

July 1, 2005

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

April 18, 2017

Results First Posted

February 18, 2015

Record last verified: 2017-04

Locations

US(3)