Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

Vestibular Schwannoma Clinical Trial

Official title:

Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite Remaining Vestibular Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02379754
• Other study ID #: VS-FT-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Drug:
• Gentamicins
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Locations

Country	Name	City	State
Sweden	Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjö P, Tjernström F. Vestibular "PREHAB". Ann N Y Acad Sci. 2009 May;1164:257-62. doi: 10.1111/j.1749-6632.2009.03778.x. — View Citation

Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjö 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 — View Citation

Magnusson M, Karlberg M, Tjernström 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. — View Citation

Magnusson M, Padoan S. Delayed onset of ototoxic effects of gentamicin in treatment of Menière's disease. Rationale for extremely low dose therapy. Acta Otolaryngol. 1991;111(4):671-6. — View 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. — View Citation

Tjernström F, Fransson PA, Kahlon B, Karlberg M, Lindberg S, Siesjö 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/jn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences of needed sick-leave from work and leisure activities	Time to return to normal daily activities after surgery, both job-related and leisure activities	6 months after surgery
Primary	Differences and changes of postural control following surgery, compared to before surgery	Postural control assessed with posturography during a sensory conflict	At first vestibular assessment at the time for inclusion and 6 months after surgery
Secondary	Differences of duration of hospital stay	Hospital stay required before patients can be discharged	After surgery for the duration of the hospital stay up to two weeks
Secondary	Differences of subjective well being after surgery	Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment	Immediate time after surgery (2 weeks)
Secondary	Change of subjective well being after gentamicin treatment	Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment	Immediate time after gentamicin installation (2 weeks)
Secondary	Change of hearing levels	Measuring hearing levels (pure tone hearing and speech discrimination) before and after gentamicin treatment to determine possible detrimental effect on hearing	At first vestibular assessment and 2 weeks after gentamicin installation
Secondary	Differences in the level of stress after surgery	Daily Measures of cortisol in the saliva after surgery during the time patients are admitted to the hospital	Daily after surgery for the duration of the hospital stay up to 2 weeks
Secondary	Differences of perceived dizziness after surgery	Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)	6 months after surgery
Secondary	Differences of level of anxiety and depression	Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)	6 months after surgery
Secondary	Change of level of perceived dizziness after gentamicin	Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)	At first vestibular assessment and 6 weeks after gentamicin installation
Secondary	Differences of changes in levels of perceived dizziness after surgery as compared to before surgery	Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)	At first vestibular assessment and 6 months after surgery
Secondary	Occurrence of spontaneous nystagmus after surgery	To measure spontaneous nystagmus after surgery and its direction as a sign of vestibular deafferentation or central nervous damage	Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)
Secondary	Differences in vestibular compensation after surgery	Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation after surgery	6 months after surgery
Secondary	Change of vestibular function after gentamicin treatment	Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation and function after gentamicin treatment	6weeks after gentamicin treatment