Enhancing Facial Nerve Function With Omega-3 After Resection of Vestibular Schwannoma

NCT05116878 | Terminated DMC

• 1 other identifier: 21-007120
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to develop a therapeutic agent to help improve facial nerve outcomes and ultimately improve long-term quality-of-life following surgical resection of vestibular schwannomas. It is possible the therapeutic agent may impact tumor control rates as well, and this will also be studied. Using rigorous scientific methods, we will assess whether these factors are impacted by the treatment agent (Omega-3) versus placebo control (cellulose).

Conditions

Vestibular Schwannoma

Keywords

Facial nerve outcomes; Vestibular schwannoma resection; Acoustic neuroma; Omega-3; Nerve regeneration; Neuroprotection

Outcome Measures

Primary Outcomes (2)

• Change in facial nerve function

  Subjects will receive independent examination by at least three expert clinical assessors using the standardized, and clinically validated, House-Brackmann facial function score to characterize the severity of facial paralysis. Score is determined by measurements (in cm) of subjects movements of facial reference points on a scale of 0-8 which translate to grading system of grade I (normal) - Grade VI (no facial motion)

  Baseline, 3 and 12 months post-operative

• Tumor Control

  Number of subjects to have tumor recurrence or progression of vestibular schwannoma as assessed by post-operative radiography (MRI) imaging

  12 months post-operative

Study Arms (2)

Omega-3 Group

EXPERIMENTAL

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.

Dietary Supplement: Omega-3

Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

One capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative

Omega-3 Group

Placebo DIETARY_SUPPLEMENT

One cellulose capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VS on final pathology report
• Surgical intervention (RS, MF, TL, other)
• Primary and revision cases included, including prior radiation

You may not qualify if:

• History of liver disease or abnormal liver function tests
• Diabetic patients with specific contraindication to omega-3 supplementation
• History of bleeding disorder, or recommended use of anticoagulation (not including anti-platelets or NSAIDs) during the treatment period
• Neurofibromatosis 1 or 2, or schwanomatosis disorders
• Non-VS pathology
• Patients already taking fish oil/omega-3 supplementation.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Michael Link, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Lucas P Carlstrom, MD, PhD

  Mayo Clinic

  STUDY DIRECTOR

• Matthew L Carlson, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients and clinical providers, including outcomes assessors, will be blinded to treatment vs placebo arms. Masking will be performed by an independent trial coordinator not involved with data collection, data analysis, or patient care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blinded, placebo-controlled clinical trial

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: November 1, 2021
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)