Clinical trial NCT02333435: Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostatectomy
Omega-3 fatty acids
Quality of life
inflammation
cellular proliferation
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer (Gleason score \>= 7)
* Patient has chosen to undergo radical prostatectomy
* Patient agrees to stop taking any omega-3 supplements at least 3 months before the start of the study
* Patient has provided informed consent

Exclusion Criteria:

* Allergy to fish and sunflower
* Suffering from a bipolar disorder

Primary outcomes:
measure: Change in Prostate Cancer Proliferative Index
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Inflammatory mediators levels- Systemic
timeFrame: 6 weeks, 1 year
measure: Modulation of Inflammatory mediators levels - Prostatic
timeFrame: 6 weeks, 1 year
measure: Modulation of the Quality of life of patients
timeFrame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
measure: Modulation of the psychosocial functioning of patients
timeFrame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
measure: Impact of inflammation on Quality of life
timeFrame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
measure: Impact of inflammation on psychosocial functioning
timeFrame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Other outcomes:
measure: Fatty acid profiles in red blood cell membranes, change relative to baseline
timeFrame: 6 weeks, 3, 6, 9, 12 months post radical prostatectomy
measure: Fatty acid profiles in prostate tissue
timeFrame: 6 weeks
measure: Impact of EPA supplementation on radical prostatectomy complications
timeFrame: 6 weeks
measure: Impact of EPA supplementation on cancer aggressiveness
timeFrame: 6 weeks
measure: Change on PSA level (ng/mL), relative to baseline
timeFrame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
measure: Impact of EPA supplementation on biochemical recurrence
timeFrame: 5 years post radical prostatectomy
Locations:
city: Quebec
country: Canada
facility: Centre de Recherche Clinique et Evaluative en Oncologie - Hotel Dieu de Quebec
Study officials:
affiliation: Laval University and Hotel Dieu-de-Quebec
name: Vincent Fradet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guertin MH, Robitaille K, Pelletier JF, Duchesne T, Julien P, Savard J, Bairati I, Fradet V. Effects of concentrated long-chain omega-3 polyunsaturated fatty acid supplementation before radical prostatectomy on prostate cancer proliferation, inflammation, and quality of life: study protocol for a phase IIb, randomized, double-blind, placebo-controlled trial. BMC Cancer. 2018 Jan 10;18(1):64. doi: 10.1186/s12885-017-3979-9.