Clinical trial NCT02379754: Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function
Official title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite 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Overall status: WITHDRAWN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: 2015-03-05
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 remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

Detailed description: The residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. An acute unilateral vestibular deafferentation (uVD) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. The nausea/vertigo induced by surgery and sudden uVD both can impede vestibular compensation processes and in extension, also the need for rehabilitation. The vestibular PREHAB protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. The protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uVD over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. Through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uVD.

Eligibility criteria: Inclusion Criteria:

* diagnosed with vestibular schwannoma and surgical treatment is advised
* remaining vestibular function

Exclusion Criteria:

* impaired decision making
* no remaining vestibular function
* signs of central nervous dysfunction
* neurofibromatosis
* Patients are advised not to participate in the gentamicin arm but encouraged to participate in the 'non-gentamicin' arm:
* when hearing is better than 30decibel (dB) i pure tone average (500, 1000, 2000, 3000/4000 Hz) and speech discrimination better than 70% -when 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: Differences of duration of hospital stay
timeFrame: After surgery for the duration of the hospital stay up to two weeks
measure: Differences of subjective well being after surgery
timeFrame: Immediate time after surgery (2 weeks)
measure: Change of subjective well being after gentamicin treatment
timeFrame: Immediate time after gentamicin installation (2 weeks)
measure: Change of hearing levels
timeFrame: At first vestibular assessment and 2 weeks 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 perceived dizziness after surgery
timeFrame: 6 months after surgery
measure: Differences of level of anxiety and depression
timeFrame: 6 months after surgery
measure: Change of level of perceived dizziness after gentamicin
timeFrame: At first vestibular assessment and 6 weeks after gentamicin installation
measure: Differences of changes in levels of perceived dizziness after surgery as compared to before surgery
timeFrame: At first vestibular assessment and 6 months after surgery
measure: Occurrence of spontaneous nystagmus after surgery
timeFrame: Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)
measure: Differences in vestibular compensation after surgery
timeFrame: 6 months after surgery
measure: Change of vestibular function after gentamicin treatment
timeFrame: 6weeks 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: 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.
citation: Postema RJ, Kingma CM, Wit HP, Albers FW, Van Der Laan BF. Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial. Acta Otolaryngol. 2008 Aug;128(8):876-80. doi: 10.1080/00016480701762458.