Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 12:58 PM
Study NCT ID:
NCT02333435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life
Sponsor:
CHU de Quebec-Universite Laval
Organization:
Study Overview
Official Title:
Étude randomisée, contrôlée, de Phase II, Effets d'un Supplement d'oméga-3 (EPA) Sur l'Inflammation, la prolifération Cellulaire et la qualité de Vie Chez Des Patients Avec Cancer de la Prostate traités Par Prostatectomie Radicale
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT-EPA
Brief Summary:
Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated with a major individual and societal burden. Although still controversial, the literature suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against prostate cancer. One of the proposed mechanisms of action of ω3 lies in their anti-inflammatory properties. In addition, there are some observational evidences suggesting an association of ω3 intake with a lower rate of depression in cancer patients. However, no clinical study has tested the efficacy of ω3 supplementation on psychological and quality of life outcomes in that population. Several evidences point to a possible involvement of inflammation in psychological issues. Reducing the systemic inflammatory state may have beneficial impact on the quality of life of these patients. Preliminary work from this team of investigators, in a cohort of patients managed with active surveillance for their low-grade prostate cancer, show a strong inverse association between the risk of prostate cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a type of ω3).
HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life.
The investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. The presence of high-grade cancer will be mandatory.
The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. The potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative level of prostate specific antigen and diet.
This project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this trial will serve as solid basis for a large-scale phase III clinical trial.
HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life.
The investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. The presence of high-grade cancer will be mandatory.
The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. The potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative level of prostate specific antigen and diet.
This project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this trial will serve as solid basis for a large-scale phase III clinical trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: