Clinical trial · Interventional
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
NCT00253643CI-TRIAL-00027056completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fish oil | Dietary Supplement | — | UNRESOLVED |
| green tea catechin extract | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (FO, GT catechin extract)
- description
- Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
- interventionNames
- Dietary Supplement: green tea catechin extract
- Dietary Supplement: fish oil
- type
- EXPERIMENTAL
- label
- ArmII (FO placebo, GT catechin extract)
- description
- Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
- interventionNames
- Dietary Supplement: green tea catechin extract
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm III (FO, GT placebo)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 participationReferences
Publications (1)
- DERIVEDZhang 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 27646578