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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
Awards & highlights
EFFORTS Trial Summary
This trial will test whether Omega-3 supplements can improve facial nerve function and quality of life after surgery to remove a vestibular schwannoma (a type of brain tumor). The trial will also look at whether Omega-3 affects the tumor itself.
Eligible Conditions
- Acoustic Neuroma
EFFORTS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
EFFORTS 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
3,206 Previous Clinical Trials
3,767,069 Total Patients Enrolled
Michael Link, MDPrincipal InvestigatorMayo Clinic
Lucas P Carlstrom, MD, PhDStudy DirectorMayo Clinic
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for participants in this clinical investigation?
"As per the details sourced from clinicaltrials.gov, this medical trial is still recruiting patients. It was commenced on November 1st 2021 and most recently updated on November 11th 2022."
Answered by AI
What is the scale of recruitment for this experiment?
"Affirmative. Clinicaltrials.gov data indicate that the experiment is currently recruiting patients, which began on November 1st 2021 and was most recently updated on November 11th 2022. This research requires 200 participants from one medical centre to participate in it."
Answered by AI
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