Clinical trial NCT02415257: Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function
Official title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Vestibular Schwannoma
Keywords: Vestibular schwannoma
acoustic neuroma
cerebellopontine angle tumour
gentamicin
rehabilitation
postural balance
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques

Detailed description: Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)

Eligibility criteria: Inclusion Criteria:

* Vestibular schwannoma advised to surgical treatment
* No measurable remaining vestibular function

Exclusion Criteria:

* impaired decision making
* neurofibromatosis
* signs for central dysfunction
* remaining vestibular function
* Patients are advised not to participate in the gentamicin arm if
* hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%
* the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss

Primary outcomes:
measure: Differences and changes of postural control following surgery, compared to before surgery
timeFrame: At first vestibular assessment at the time for inclusion and 6 months after surgery
Secondary outcomes:
measure: Occurrence of spontaneous nystagmus after surgery
timeFrame: Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)
measure: Change of hearing levels
timeFrame: At first vestibular assessment and 4weeks after gentamicin installation
measure: Differences in the level of stress after surgery
timeFrame: Daily after surgery for the duration of the hospital stay, up to 2 weeks
measure: Differences of subjective well being after surgery
timeFrame: Immediate time after surgery (2weeks)
measure: Differences of duration of hospital stay
timeFrame: After surgery for the duration of the hospital stay up to 2 weeks
measure: Differences of subjective well being after gentamicin treatment
timeFrame: Immediate time after gentamicin treatment (2weeks)
measure: Differences of perceived dizziness after surgery
timeFrame: 6 months after surgery
measure: Differences of perceived anxiety/depression after surgery
timeFrame: 6 months after surgery
measure: Change of level of perceived dizziness after surgery as compared to before surgery
timeFrame: At first vestibular assessment (inclusion) and 6 months after surgery
measure: Change of level of perceived anxiety/depression after surgery as compared to before surgery
timeFrame: At first vestibular assessment (inclusion) and 6 months after surgery
measure: Differences in vestibular compensation after surgery
timeFrame: 6 months after surgery
measure: Change of vestibular function after gentamicin treatment
timeFrame: 6 weeks after gentamicin treatment
Other outcomes:
measure: Differences of needed sick-leave from work and leisure activities
timeFrame: 6 months after surgery
Locations:
city: Lund
country: Sweden
facility: Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
Study officials:
affiliation: Lund University
name: Fredrik Tjernström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parietti-Winkler C, Gauchard GC, Simon C, Perrin PP. Visual sensorial preference delays balance control compensation after vestibular schwannoma surgery. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1287-94. doi: 10.1136/jnnp.2007.135913. Epub 2008 Aug 1.
citation: Magnusson M, Padoan S. Delayed onset of ototoxic effects of gentamicin in treatment of Meniere's disease. Rationale for extremely low dose therapy. Acta Otolaryngol. 1991;111(4):671-6. doi: 10.3109/00016489109138398.
citation: Tjernstrom F, Fransson PA, Kahlon B, Karlberg M, Lindberg S, Siesjo P, Magnusson M. Vestibular PREHAB and gentamicin before schwannoma surgery may improve long-term postural function. J Neurol Neurosurg Psychiatry. 2009 Nov;80(11):1254-60. doi: 10.1136/jnnp.2008.170878. Epub 2009 Jul 1.
citation: Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjo P, Tjernstrom F. Vestibular "PREHAB". Ann N Y Acad Sci. 2009 May;1164:257-62. doi: 10.1111/j.1749-6632.2009.03778.x.
citation: Magnusson M, Karlberg M, Tjernstrom F. 'PREHAB': Vestibular prehabilitation to ameliorate the effect of a sudden vestibular loss. NeuroRehabilitation. 2011;29(2):153-6. doi: 10.3233/NRE-2011-0689.
citation: Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjo P. Preoperative vestibular ablation with gentamicin and vestibular 'prehab' enhance postoperative recovery after surgery for pontine angle tumours--first report. Acta Otolaryngol. 2007 Dec;127(12):1236-40. doi: 10.1080/00016480701663433.