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

Prostate Cancer Clinical Trial

— RCT-EPA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02333435
• Other study ID #: 2012-1012
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• EPA
3g/day of purified EPA , capsules, taken once daily, for 14 months
• Placebo
3g/day of placebo (high oleic sunflower oil) , capsules, taken once daily, for 14 months

Locations

Country	Name	City	State
Canada	Centre de Recherche Clinique et Evaluative en Oncologie - Hotel Dieu de Quebec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatty acid profiles in red blood cell membranes, change relative to baseline	The difference of fatty acid levels between both groups, relative to baseline, will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.	6 weeks, 3, 6, 9, 12 months post radical prostatectomy
Other	Fatty acid profiles in prostate tissue	The difference of fatty acid levels between both groups at prostatectomy will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids, and in absolute level (mg per gram of tissue).	6 weeks
Other	Impact of EPA supplementation on radical prostatectomy complications	The difference in perioperative bleeding, laboratory tests (hemoglobin, hematocrit and platelets) and surgical complications between both group will be examined at surgery.	6 weeks
Other	Impact of EPA supplementation on cancer aggressiveness	Pathological reclassification of cancer grade (ISUP grading system) and stage between the prostate diagnostic biopsy and the prostatectomy specimen will be compared between both groups.	6 weeks
Other	Change on PSA level (ng/mL), relative to baseline	PSA change relative to baseline will be measured for both groups.	6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Other	Impact of EPA supplementation on biochemical recurrence	The biochemical recurrence, defined as a PSA level = 0.2 ng/mL after reaching a non-detectable level at three months post-surgery, will be evaluated for both groups.	5 years post radical prostatectomy
Primary	Change in Prostate Cancer Proliferative Index	At 6 weeks post study entry, the prostate of the patient will be removed by prostatectomy. The tissue will be preserved in paraffin blocks. The tumour will be identified and the level of Ki-67 in the tumour will be quantified.	6 weeks
Secondary	Change in Inflammatory mediators levels- Systemic	The changes in levels of systemic inflammatory mediators, relative to their baseline levels, at the time of radical prostatectomy and at one year post-radical prostatectomy, will be measured. The levels of mediators will be expressed in pg/mL and quantified using validated techniques.	6 weeks, 1 year
Secondary	Modulation of Inflammatory mediators levels - Prostatic	The differences in the levels of expression of inflammatory mediators between both treatment groups will be measured in the peripheral zone of the prostate before surgical prostate dissection/ischemia. The levels of mediators will be expressed in pg/mL and quantified using validated techniques. Further validation could be performed using immunohistochemistry techniques.	6 weeks, 1 year
Secondary	Modulation of the Quality of life of patients	Validated questionnaires will be used to measure the modulation of the treatment on Quality of Life of the patients, which will include questions on mood, anxiety levels, sleep and cognition.	6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Secondary	Modulation of the psychosocial functioning of patients	Validated questionnaires will be used to measure the modulation of the treatment on psychosocial functioning of the patients, which will include questions on mood, anxiety levels, sleep and cognition.	6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Secondary	Impact of inflammation on Quality of life	The impact of changes in inflammatory mediators levels induced by EPA supplementation on quality of life scores will be measured. To do so, we will use appropriate and powerful statistical tests.	6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Secondary	Impact of inflammation on psychosocial functioning	The impact of changes in inflammatory mediators levels induced by EPA supplementation and changes in psychosocial functioning scores will be measured. To do so, we will use appropriate and powerful statistical tests.	6 weeks, 3, 6, 9 and 12 months post radical prostatectomy