N/A
N=89
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Precancerous Condition · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00253643 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) — 147; 158.8; 138.3; 102.3 units on a scale — p=0.1521
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- green tea catechin extract (Dietary_supplement); fish oil (Dietary_supplement); placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) |
147; 158.8; 138.3; 102.3; 140.7; 159.3 | 0.1521 |
| PRIMARY Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention |
18.5; 8; 10; 12 | 0.1573 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00253643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.