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Omega-3 Fatty Acid Supplement

Omega-3 Fish Oil Supplement for Prostate Cancer (RCT-EPAII-BCR Trial)

Q: How many participants are being enrolled in this medical research study?

Affirmative, the details on clinicaltrials.gov demonstrate that this research is open for recruitment. The trial was initially posted on July 10th 2017 and its most recent amendment occurred March 15th 2022; 40 individuals are required to be enrolled from one medical facility.

Q: To what degree is MAG-EPA hazardous to human health?

There is some clinical evidence that MAG-EPA holds a degree of safety, so it received an assessment score of 2.

Q: Is this research trial confined to individuals aged 50 or older, or are younger participants also eligible?

According to the inclusion criteria, this study is open to individuals aged between 18 and 100. Additionally, there are 84 clinical trials dedicated solely for those below 18 years of age and 1,368 specifically designed for seniors 65 or older.

Q: For whom is enrollment in this investigation available?

The enrolment criteria for this study requires <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> patients aged 18 to 100. The research team is aiming to recruit about 40 participants in total.

Q: Are there any remaining vacancies in this clinical investigation?

Clinicaltrials.gov currently displays this medical trial as actively recruiting. It was launched on the 10th of July 2017, and its listing was last modified on March 15th 2022.

Phase 2

Recruiting

Led By Vincent Fradet, MD, PhD

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate

Patients must have a PSA failure defined as PSA of >= 0.5 ng/ml that has increased above nadir following radical prostatectomy (RP) or a PSA increase of 2.0 above post-therapy nadir after radiotherapy (RT) or a PSA increase between 0.05-0.49 ng/ml that has increased above nadir following RP. The maximal PSA value at enrolment must be <5.0 ng/mL after RP and <6 ng/mL after RT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9,12 months

Awards & highlights

RCT-EPAII-BCR Trial Summary

This trial will test the effects of an omega-3-rich fish oil supplement on men with prostate cancer who are at risk of side effects from androgen deprivation therapy.

Who is the study for?

Men with prostate cancer who've had surgery or radiotherapy but are now seeing a rise in PSA levels, indicating potential cancer return. They must not have metastatic disease, be free from certain medications and supplements for the last 3 months, and cannot have allergies to fish or sunflower.Check my eligibility

What is being tested?

The trial is testing if taking a high dose of omega-3-rich fish oil (MAG-EPA) daily can delay the need for more aggressive therapy in men whose prostate cancer may be returning. A placebo group will serve as a comparison to see if there's any benefit.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones from omega-3 supplements could include an upset stomach, fishy aftertaste, and increased risk of bleeding. The study excludes those allergic to its components to minimize risks.

RCT-EPAII-BCR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer diagnosis was confirmed through tissue examination.

Select...

My PSA levels have risen after prostate cancer treatment but are below 5 ng/mL after surgery or below 6 ng/mL after radiation.

RCT-EPAII-BCR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9,12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prostate-specific antigen (PSA) doubling time from baseline to 12 months.

Secondary outcome measures

Fatty acid profiles in red blood cells, changes relative to baseline (time 0).

RCT-EPAII-BCR Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MAG-EPA groupExperimental Treatment1 Intervention

5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.

Group II: Placebo groupPlacebo Group1 Intervention

5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Icosapent

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,117 Total Patients Enrolled

12 Trials studying Prostate Cancer

3,802 Patients Enrolled for Prostate Cancer

Vincent Fradet, MD, PhDPrincipal InvestigatorCHU de Québec-Univeristé Laval

1 Previous Clinical Trials

130 Total Patients Enrolled

1 Trials studying Prostate Cancer

130 Patients Enrolled for Prostate Cancer

Media Library

MAG-EPA (Omega-3 Fatty Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03753334 — Phase 2

Prostate Cancer Research Study Groups: Placebo group, MAG-EPA group

Prostate Cancer Clinical Trial 2023: MAG-EPA Highlights & Side Effects. Trial Name: NCT03753334 — Phase 2

MAG-EPA (Omega-3 Fatty Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03753334 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in this medical research study?

"Affirmative, the details on clinicaltrials.gov demonstrate that this research is open for recruitment. The trial was initially posted on July 10th 2017 and its most recent amendment occurred March 15th 2022; 40 individuals are required to be enrolled from one medical facility."

Answered by AI

To what degree is MAG-EPA hazardous to human health?

"There is some clinical evidence that MAG-EPA holds a degree of safety, so it received an assessment score of 2."

Answered by AI

Is this research trial confined to individuals aged 50 or older, or are younger participants also eligible?

"According to the inclusion criteria, this study is open to individuals aged between 18 and 100. Additionally, there are 84 clinical trials dedicated solely for those below 18 years of age and 1,368 specifically designed for seniors 65 or older."

Answered by AI

For whom is enrollment in this investigation available?

"The enrolment criteria for this study requires prostate cancer patients aged 18 to 100. The research team is aiming to recruit about 40 participants in total."

Answered by AI

Are there any remaining vacancies in this clinical investigation?

"Clinicaltrials.gov currently displays this medical trial as actively recruiting. It was launched on the 10th of July 2017, and its listing was last modified on March 15th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03753334.

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