Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function
Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 stayDifferences 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.
Eligibility
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
Locations and Contacts
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
Additional Information
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
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