Evidence map›Paper›PMID 29321047›Full record

Trial reportBMC cancer2018

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.

Marie-Hélène Guertin, Karine Robitaille, Jean-François Pelletier, Thierry Duchesne, Pierre Julien, Josée Savard, Isabelle Bairati, Vincent Fradet

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02333435 (Étude randomisée, contrôlée, de Phase II, Effets d'un Supplement d'oméga-3), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02333435 phase2active not recruitingnot on this map

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

TypeinterventionalSponsorCHU de Quebec-Universite LavalRan2015 to 2025Enrolled130ConditionsProstate CancerArmsEPA, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Immunomodulatory Activities of Body Wall Fatty Acids Extracted fromJournal of microbiology and biotechnology · 2020
    Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Marie-Hélène GuertinOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Karine RobitailleOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Jean-François PelletierOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Thierry DuchesneMathematics and Statistics Department, Université Laval, 1045 avenue de la médecine, Bureau, Québec, QC, 1056, Canada.
Pierre JulienEndocrinology and Nephrology Unit, Centre de recherche du CHU de Québec - Université Laval - CHUL, 2705, boulevard Laurier, Québec, QC, Canada.
Josée SavardOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Isabelle BairatiOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Vincent FradetOncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada. vincent.fradet@fmed.ulaval.ca.
Université Laval · CAHôtel-Dieu de Québec · CAWilfrid Laurier University · CA

Funding

Lotte and John Hecht Memorial Foundation Innovation Grant of the Canadian Cancer Society Research Institute 702569
6 · The paper itself

Abstract

backgroundProstate cancer is the most commonly diagnosed cancer in north-American men. Few dietary or lifestyle interventions have been tested to prevent prostate cancer progression. Omega-3 fatty acid supplementation represents a promising intervention for prostate cancer patients. The aim of the study is to evaluate the effects of long-chain omega-3 polyunsaturated fatty acids (LCn3), more precisely eicosapentaenoic acid monoacylglyceride (MAG-EPA) supplementation, on prostate cancer proliferation, inflammation mediators and quality of life among men who will undergo radical prostatectomy. METHODS/

designWe propose a phase IIb, randomized, double-blind placebo-controlled trial of MAG-EPA supplementation for 130 men who will undergo radical prostatectomy as treatment for a prostate cancer of Gleason score ≥ 7 in an academic cancer center in Quebec City. Participants will be randomized to 6 capsules of 625 mg of fish oil (MAG-EPA) per capsule containing 500 mg of EPA daily or to identically looking capsules of high oleic acid sunflower oil (HOSO) as placebo. The intervention begins 4 to 10 weeks prior to radical prostatectomy (baseline) and continues for one year after surgery. The primary endpoint is the proliferative index (Ki-67) measured in prostate cancer cells at radical prostatectomy. A secondary endpoint includes prostate tissue levels of inflammatory mediators (cytokines and proteins) at time of radical prostatectomy. Changes in blood levels of inflammatory mediators, relative to baseline levels, at time of radical prostatectomy and 12 months after radical prostatectomy will also be evaluated. Secondary endpoints also include important aspects of psychosocial functioning and quality of life such as depression, anxiety, sleep disturbances, fatigue, cognitive complaints and prostate cancer-specific quality of life domains. The changes in these outcomes, relative to baseline levels, will be evaluated at 3, 6, 9 and 12 months after radical prostatectomy. DISCUSSION: The results from this trial will provide crucial information to clarify the role of omega-3 supplementation on prostate cancer proliferation, inflammation and quality of life.

trial registrationClinicalTrials.gov Identifier: NCT02333435. Registered on December 17, 2014. Last updated September 6, 2016.

Indexed as

AdultAgedCell ProliferationDietary SupplementsDouble-Blind MethodFatty Acids, Omega-3HumansInflammationMaleMiddle AgedNutrition TherapyProstatectomyProstatic NeoplasmsTreatment OutcomeFatty Acids, Omega-3InflammationOmega-3ProliferationProstate cancerQuality of life

Identifiers

PMID29321047
PMCPMC5763552
OpenAlexW2784208716

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.