Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

Condition(s) targeted: Vestibular Schwannoma

Intervention: Gentamicins (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Lund University

Official(s) and/or principal investigator(s):
Fredrik Tjernström, MD, PhD, Principal Investigator, Affiliation: Lund University

Overall contact:
Fredrik Tjernström, MD, PhD, Phone: +46 46 175849, Email: Fredrik.Tjernstrom@med.lu.se

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Differences and changes of postural control following surgery, compared to before surgery

Secondary outcome:

Differences of duration of hospital stay

Differences of subjective well being after surgery

Change of subjective well being after gentamicin treatment

Change of hearing levels

Differences in the level of stress after surgery

Differences of perceived dizziness after surgery

Differences of level of anxiety and depression

Change of level of perceived dizziness after gentamicin

Differences of changes in levels of perceived dizziness after surgery as compared to before surgery

Occurrence of spontaneous nystagmus after surgery

Differences in vestibular compensation after surgery

Change of vestibular function after gentamicin treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Fredrik Tjernström, MD, PhD, Phone: +46 46 175849, Email: Fredrik.Tjernstrom@med.lu.se

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital, Lund 22185, Sweden; Recruiting
Fredrik Tjernström, MD, PhD, Phone: +4646 175849, Email: Fredrik.Tjernstrom@med.lu.se
Måns Magnusson, MD, PhD, Phone: +4646 171796, Email: Mans.Magnusson@med.lu.se

Related publications:

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.

Starting date: January 2015
Last updated: March 1, 2015