Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05116878 |
| Other study ID # |
21-007120 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
August 2, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. Using rigorous scientific methods, we will assess
whether these factors are impacted by the treatment agent (Omega-3) versus placebo control
(cellulose).
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.
