Impact of radiosurgery on hearing and balance in vestibular schwannoma patients
Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
This study is testing how a specific type of radiation treatment affects hearing and balance in people with vestibular schwannoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05641441 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of stereotactic radiosurgery (SRS) on patients with vestibular schwannoma, focusing on cochlear, vestibular, gustatory, and facial nerve functions. It includes both retrospective analysis of past patients treated between 2014 and 2021 and prospective follow-up of current patients. Data will be collected on demographics, clinical characteristics, and MRI features, alongside quality of life assessments through questionnaires. The aim is to evaluate the predictive value of tumor characteristics on hearing preservation and vestibular function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral vestibular schwannoma treated with either SRS or MRI-based observation.
Not a fit: Patients with previous treatments for vestibular schwannoma or those with profound hearing loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how radiosurgery affects hearing and balance, potentially leading to improved treatment strategies for vestibular schwannoma.
How similar studies have performed: While there have been studies on radiosurgery for vestibular schwannoma, this specific focus on ototoxicity and quality of life assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or above * Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study * Patients willing to take part in the study and give their informed consent Exclusion Criteria: * Previous surgical or radiation therapy for VS (including SRS) * Patients diagnosed with neurofibromatosis type II * Preexisting profound hearing loss, with a pure tone average (PTA) \>90 and word recognition score (WRS) \<10%, upon initial assessment * Previous middle ear surgery of the affected ear * Concurrent treatment with other experimental drugs
Where this trial is running
Geneva
- Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Pascal Senn
- Email: pascal.senn@hcuge.ch
- Phone: 0223728244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.