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Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Primary Purpose

Vestibular Schwannoma

Status
Withdrawn
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Gentamicin
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vestibular Schwannoma focused on measuring Vestibular schwannoma, acoustic neuroma, cerebellopontine angle tumour, gentamicin, rehabilitation, postural balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gentamicin treated

Non-gentamicin

Arm Description

Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery. Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board

Rehabilitation exercises before and after both treatment and surgery Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board

Outcomes

Primary Outcome Measures

Differences and changes of postural control following surgery, compared to before surgery
Postural control assessed with posturography during a sensory conflict

Secondary Outcome Measures

Occurrence of spontaneous nystagmus after surgery
To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage
Change of hearing levels
Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing
Differences in the level of stress after surgery
Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital
Differences of subjective well being after surgery
Daily subjective assessment of perceived vertigo/dizziness after surgery
Differences of duration of hospital stay
Length of hospital stay required before patients can be discharged
Differences of subjective well being after gentamicin treatment
Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
Differences of perceived dizziness after surgery
Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
Differences of perceived anxiety/depression after surgery
Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
Change of level of perceived dizziness after surgery as compared to before surgery
Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
Change of level of perceived anxiety/depression after surgery as compared to before surgery
Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
Differences in vestibular compensation after surgery
Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery
Change of vestibular function after gentamicin treatment
Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment

Full Information

First Posted
January 26, 2015
Last Updated
September 9, 2020
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02415257
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Vestibular schwannoma, acoustic neuroma, cerebellopontine angle tumour, gentamicin, rehabilitation, postural balance

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gentamicin treated
Arm Type
Experimental
Arm Description
Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery. Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board
Arm Title
Non-gentamicin
Arm Type
No Intervention
Arm Description
Rehabilitation exercises before and after both treatment and surgery Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Other Intervention Name(s)
prehabituation
Intervention Description
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
Primary Outcome Measure Information:
Title
Differences and changes of postural control following surgery, compared to before surgery
Description
Postural control assessed with posturography during a sensory conflict
Time Frame
At first vestibular assessment at the time for inclusion and 6 months after surgery
Secondary Outcome Measure Information:
Title
Occurrence of spontaneous nystagmus after surgery
Description
To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage
Time Frame
Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)
Title
Change of hearing levels
Description
Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing
Time Frame
At first vestibular assessment and 4weeks after gentamicin installation
Title
Differences in the level of stress after surgery
Description
Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital
Time Frame
Daily after surgery for the duration of the hospital stay, up to 2 weeks
Title
Differences of subjective well being after surgery
Description
Daily subjective assessment of perceived vertigo/dizziness after surgery
Time Frame
Immediate time after surgery (2weeks)
Title
Differences of duration of hospital stay
Description
Length of hospital stay required before patients can be discharged
Time Frame
After surgery for the duration of the hospital stay up to 2 weeks
Title
Differences of subjective well being after gentamicin treatment
Description
Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
Time Frame
Immediate time after gentamicin treatment (2weeks)
Title
Differences of perceived dizziness after surgery
Description
Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
Time Frame
6 months after surgery
Title
Differences of perceived anxiety/depression after surgery
Description
Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame
6 months after surgery
Title
Change of level of perceived dizziness after surgery as compared to before surgery
Description
Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
Time Frame
At first vestibular assessment (inclusion) and 6 months after surgery
Title
Change of level of perceived anxiety/depression after surgery as compared to before surgery
Description
Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame
At first vestibular assessment (inclusion) and 6 months after surgery
Title
Differences in vestibular compensation after surgery
Description
Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery
Time Frame
6 months after surgery
Title
Change of vestibular function after gentamicin treatment
Description
Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment
Time Frame
6 weeks after gentamicin treatment
Other Pre-specified Outcome Measures:
Title
Differences of needed sick-leave from work and leisure activities
Description
Time for return to normal daily activities after surgery, both job-related and leisure.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Tjernström, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18676407
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.
Results Reference
background
PubMed Identifier
1950529
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.
Results Reference
background
PubMed Identifier
19574236
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.
Results Reference
result
PubMed Identifier
19645909
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.
Results Reference
result
PubMed Identifier
22027076
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.
Results Reference
result
PubMed Identifier
17917842
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.
Results Reference
result

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Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

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