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Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life

Study acronym: RCT-EPA
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Primary completion date: Dec 2020 to Dec 1, 2020
    • Start date: Jan 2015 to Feb 12, 2015
    • Site details revised
    v12
  2. Minor Study completion date: Dec 2023 to Dec 2025v11
  3. Minor Re-verified, no change to tracked fieldsv10
  4. Minor Study completion date: Dec 2021 to Dec 2023v9
  5. Minor Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary completion date: Dec 2019 to Dec 2020
    • Study completion date: Dec 2019 to Dec 2021
    v7
  2. Notable Primary completion date: Feb 2019 to Dec 2019v6
  3. Notable Primary completion date: Feb 2018 to Feb 2019
    • Study completion date: Dec 2018 to Dec 2019
    v5
  4. Notable Primary completion date: Jul 2017 to Feb 2018
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2018 to Dec 2018
    • Site details revised
    v4
  5. Minor Eligibility criteria revised
    • Site contact updated
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Jul 2018
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02333435
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)
Prostate Cancer
Related terms Hyperplasia, Inflammation, Prostatic Neoplasms
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov