Vestibular SchwannomaEFFORTSNCT05116878
Enhancing Facial Nerve Function With Omega-3 After Resection of Vestibular Schwannoma
A study testing Omega-3 in people with Vestibular Schwannoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VS on final pathology report
- Surgical intervention (RS, MF, TL, other)
- Primary and revision cases included, including prior radiation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection
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).
Read the detailed description
Vestibular schwannomas (VS) are common, often-benign intracranial neoplasms, however surgical resection carries high risk of causing neurologic impairments that may severely impact patient quality-of-life. The most morbid common postoperative deficit is facial weakness due to the close anatomic proximity of VS with the facial nerve, which is frequently stretched and attenuated by the tumor itself, and subject to additional mechanical stress during surgery. In addition to disfiguring cosmesis, facial weakness carries the secondary effects of abnormal speech, ocular morbidity from inadequate eye closure and corneal lubrication, and dysfunctional swallowing mechanics. Some patients may eventually recover partial facial nerve function; however, this is an unreliable process that proceeds slowly over months to years, if at all. At present, no pharmacologic avenue exists for promoting facial nerve neuroprotection or regeneration. Correspondingly, the development of a therapeutic agent to stimulate improved facial nerve outcomes would markedly enhance patient outcomes and quality-of-life.
In the anterior skull base, loss of olfaction is a common sequela of following endoscopic surgical resection due to direct nerve manipulation, impacting approximately 25% of patients who undergo endoscopic endonasal tumor resection. In a recent randomized clinical trial, postoperative supplementation with omega-3 yielded a significant, sustained 1-2-point improvements on the University of Pennsylvania Smell Identification Test as assessed at six weeks, three months, and six months post-operatively. Although mechanistic understanding of the relationship between omega-3 supplementation and olfactory function preservation is incompletely understood, preliminary data support the hypothesis of direct neural regeneration and/or neuro-protective effects through anti-demyelination effects. More specifically, polyunsaturated fatty acids have been shown to modulate neural plasticity and provide a protective role in maintaining functional neuronal cell membranes thought to be critical for maintaining nerve connectivity and function. It is also possible that omega-3, a known anti-inflammatory agent through reducing local IL-6, TNF, NFkB, impacts the innate immune system to mitigate demyelination and other destructive post-treatment inflammatory injuries to cranial nerves and surrounding support cells. Given the highly interrelated mechanisms-of-injury resulting in olfactory deficit after anterior skull base surgery and facial weakness after VS resection, application of omega-3 fatty acids may provide similar benefits with respect to facial nerve protection and/or rehabilitation. As a fascinating aside, new pre-clinic animal model evidence also suggests that omega-3 fatty acid supplementation may result in delayed progression in a neuroblastoma xenograft model. These effects are attributed to anti-inflammatory and anti-angiogenic effects via anti-VEGF and other anti-proliferative growth factors; factors also implicated in VS pathophysiology, suggesting that omega-3 may also impact early tumor control as well. We hypothesize that post-operative omega-3 supplementation will improve facial nerve function following resection of vestibular schwannomas and enhance early tumor control rates.
- Conditions
- Vestibular Schwannoma
- Being tested
- Omega-3, Placebo
- Keywords
- Facial nerve outcomes, Vestibular schwannoma resection, Acoustic neuroma, Omega-3, Nerve regeneration, Neuroprotection
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
One capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative
PlaceboDietary supplement
One cellulose capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Nov 2021
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Why it stopped: Lack of Funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Link, Mayo Clinic
- Investigators
- Michael Link, MD, Principal investigator, Mayo ClinicLucas P Carlstrom, MD, PhD, Study director, Mayo ClinicMatthew L Carlson, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116878
- Sponsor's protocol ID
- 21-007120
- Acronym
- EFFORTS
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: May be available on specific requests for collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection
- ClinicalTrials.gov ID
- NCT05116878
- Acronym / sponsor ID
- EFFORTS / 21-007120
- Conditions
- Vestibular Schwannoma
- Keywords
- Facial nerve outcomes, Vestibular schwannoma resection, Acoustic neuroma, Omega-3, Nerve regeneration, Neuroprotection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Vestibular schwannomas (VS) are common, often-benign intracranial neoplasms, however surgical resection carries high risk of causing neurologic impairments that may severely impact patient quality-of-life. The most morbid common postoperative deficit is facial weakness due to the close anatomic proximity of VS with the facial nerve, which is frequently stretched and attenuated by the tumor itself, and subject to additional mechanical stress during surgery. In addition to disfiguring cosmesis, facial weakness carries the secondary effects of abnormal speech, ocular morbidity from inadequate eye closure and corneal lubrication, and dysfunctional swallowing mechanics. Some patients may eventually recover partial facial nerve function; however, this is an unreliable process that proceeds slowly over months to years, if at all. At present, no pharmacologic avenue exists for promoting facial nerve neuroprotection or regeneration. Correspondingly, the development of a therapeutic agent to stimulate improved facial nerve outcomes would markedly enhance patient outcomes and quality-of-life.
In the anterior skull base, loss of olfaction is a common sequela of following endoscopic surgical resection due to direct nerve manipulation, impacting approximately 25% of patients who undergo endoscopic endonasal tumor resection. In a recent randomized clinical trial, postoperative supplementation with omega-3 yielded a significant, sustained 1-2-point improvements on the University of Pennsylvania Smell Identification Test as assessed at six weeks, three months, and six months post-operatively. Although mechanistic understanding of the relationship between omega-3 supplementation and olfactory function preservation is incompletely understood, preliminary data support the hypothesis of direct neural regeneration and/or neuro-protective effects through anti-demyelination effects. More specifically, polyunsaturated fatty acids have been shown to modulate neural plasticity and provide a protective role in maintaining functional neuronal cell membranes thought to be critical for maintaining nerve connectivity and function. It is also possible that omega-3, a known anti-inflammatory agent through reducing local IL-6, TNF, NFkB, impacts the innate immune system to mitigate demyelination and other destructive post-treatment inflammatory injuries to cranial nerves and surrounding support cells. Given the highly interrelated mechanisms-of-injury resulting in olfactory deficit after anterior skull base surgery and facial weakness after VS resection, application of omega-3 fatty acids may provide similar benefits with respect to facial nerve protection and/or rehabilitation. As a fascinating aside, new pre-clinic animal model evidence also suggests that omega-3 fatty acid supplementation may result in delayed progression in a neuroblastoma xenograft model. These effects are attributed to anti-inflammatory and anti-angiogenic effects via anti-VEGF and other anti-proliferative growth factors; factors also implicated in VS pathophysiology, suggesting that omega-3 may also impact early tumor control as well. We hypothesize that post-operative omega-3 supplementation will improve facial nerve function following resection of vestibular schwannomas and enhance early tumor control rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Group | Experimental | Dietary Supplement: Omega-3Subjects 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. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- VS on final pathology report
- Surgical intervention (RS, MF, TL, other)
- Primary and revision cases included, including prior radiation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3One capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative | Dietary supplement | Omega-3 Group |
| PlaceboOne cellulose capsule orally twice daily beginning 3 days prior to clinical care surgical intervention and continuing 6 weeks post-operative | Dietary supplement | Placebo Group |
Primary outcome
Change in facial nerve function
Time frame: Baseline, 3 and 12 months post-operative
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)
Tumor Control
Time frame: 12 months post-operative
Number of subjects to have tumor recurrence or progression of vestibular schwannoma as assessed by post-operative radiography (MRI) imaging
Results and safety
The study was stopped early (reason given: Lack of Funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. May be available on specific requests for collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Link, MD principal investigator
Mayo Clinic
Lucas P Carlstrom, MD, PhD study director
Mayo Clinic
Matthew L Carlson, MD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Vestibular Schwannoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of Funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial nerve function (time frame: Baseline, 3 and 12 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.