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Omega-3 Fatty Acid
Omega-3 for Acoustic Neuroma (EFFORTS Trial)
N/A
Waitlist Available
Led By Michael Link, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 12 months post-operative
Summary
This trial is testing if omega-3 supplements can help patients who have had surgery to remove a benign brain tumor. The goal is to see if omega-3 can protect and repair facial nerves, improving recovery and quality of life. Omega-3 fatty acids have been studied for their potential to improve neural function, reduce inflammation, and aid in recovery following various types of surgeries.
Eligible Conditions
- Acoustic Neuroma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 and 12 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 12 months post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in facial nerve function
Tumor Control
Side effects data
From 2019 Phase 4 trial • 69 Patients • NCT0139648614%
Nausea/Vomit/Diarrhea
5%
Increased Appetite
5%
Cold/Infection/Allergy
5%
Insomnia
5%
Pulmonary
5%
Earache
5%
Thirsty
5%
Neurological
5%
Headache
5%
Tics
5%
Musculoskeletal
5%
Autonomic
5%
Dizzy/Lightheaded
5%
Agitated with Homicidal Statements
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omega-3/Placebo
Omega-3/Inositol
Placebo/Inositol
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omega-3 GroupExperimental Treatment1 Intervention
Subjects will receive omega-3 supplementation (Nature's Bounty Fish Oil 1400 mg, containing 980 mg Omega-3 per capsule), to begin taking 3 days prior to surgical resection of their vestibular schwannoma. Subjects will continue to take the omega-3 supplementation for 6 weeks post-operatively.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will receive a placebo to begin taking 3 days prior to clinical care of surgical resection of vestibular schwannoma. Subjects will continue to take the placebo for 6 weeks post-operatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3
2012
Completed Phase 4
~1760
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,130 Total Patients Enrolled
Michael Link, MDPrincipal InvestigatorMayo Clinic
Lucas P Carlstrom, MD, PhDStudy DirectorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of bleeding disorder or need to take blood-thinning medication during the study.You have specific rare genetic disorders called neurofibromatosis 1 or 2, or schwanomatosis.You don't have any significant medical conditions that would interfere with the study.If you have diabetes and cannot take omega-3 supplements for specific reasons, you cannot participate.You are currently taking fish oil or omega-3 supplements.
Research Study Groups:
This trial has the following groups:- Group 1: Omega-3 Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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