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Spots Global Cancer Trial Database for Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

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Trial Identification

Brief Title: Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Official Title: Étude Pilote randomisée de Phase IIB, contrôlée Par placébo, évaluant l'Effet thérapeutique d'Une supplémentation en Omega-3 (Principalement EPA) Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate.

Study ID: NCT03753334

Conditions

Prostate Cancer

Study Description

Brief Summary: Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects. Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment. This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec, Québec, Quebec, Canada

Contact Details

Name: Vincent Fradet, MD, PhD

Affiliation: CHU de Québec-Univeristé Laval

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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