ClinicalTrials.gov
ClinicalTrials.gov Menu

Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02415257
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Fredrik Tjernström, Lund University

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

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Drug: Gentamicin Phase 4

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Gentamicin treated

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

Drug: Gentamicin
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
Other Name: prehabituation

No Intervention: Non-gentamicin
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



Primary Outcome Measures :
  1. Differences and changes of postural control following surgery, compared to before surgery [ Time Frame: At first vestibular assessment at the time for inclusion and 6 months after surgery ]
    Postural control assessed with posturography during a sensory conflict


Secondary Outcome Measures :
  1. Occurrence of spontaneous nystagmus after surgery [ Time Frame: Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks) ]
    To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage

  2. Change of hearing levels [ Time Frame: At first vestibular assessment and 4weeks after gentamicin installation ]
    Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing

  3. Differences in the level of stress after surgery [ Time Frame: Daily after surgery for the duration of the hospital stay, up to 2 weeks ]
    Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital

  4. Differences of subjective well being after surgery [ Time Frame: Immediate time after surgery (2weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after surgery

  5. Differences of duration of hospital stay [ Time Frame: After surgery for the duration of the hospital stay up to 2 weeks ]
    Length of hospital stay required before patients can be discharged

  6. Differences of subjective well being after gentamicin treatment [ Time Frame: Immediate time after gentamicin treatment (2weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment

  7. Differences of perceived dizziness after surgery [ Time Frame: 6 months after surgery ]
    Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)

  8. Differences of perceived anxiety/depression after surgery [ Time Frame: 6 months after surgery ]
    Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)

  9. Change of level of perceived dizziness after surgery as compared to before surgery [ Time Frame: At first vestibular assessment (inclusion) and 6 months after surgery ]
    Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)

  10. Change of level of perceived anxiety/depression after surgery as compared to before surgery [ Time Frame: At first vestibular assessment (inclusion) and 6 months after surgery ]
    Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)

  11. Differences in vestibular compensation after surgery [ Time Frame: 6 months after surgery ]
    Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery

  12. Change of vestibular function after gentamicin treatment [ Time Frame: 6 weeks after gentamicin treatment ]
    Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment


Other Outcome Measures:
  1. Differences of needed sick-leave from work and leisure activities [ Time Frame: 6 months after surgery ]
    Time for return to normal daily activities after surgery, both job-related and leisure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415257


Contacts
Contact: Fredrik Tjernström, MD, PhD +46 46 175849 Fredrik.Tjernstrom@med.lu.se
Contact: Måns Magnusson, MD, PhD +46 46 171796 Mans.Magnusson@med.lu.se

Locations
Sweden
Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital Recruiting
Lund, Sweden, 22185
Contact: Fredrik Tjernström, MD, PhD    +46 46 175849    Fredrik.Tjernstrom@med.lu.se   
Contact: Måns Magnusson, MD, PhD    +4646 171796    Mans.Magnusson@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Fredrik Tjernström, MD, PhD Lund University

Publications of Results:
Other Publications:
Responsible Party: Fredrik Tjernström, MD, PhD, Lund University
ClinicalTrials.gov Identifier: NCT02415257     History of Changes
Other Study ID Numbers: VS-FT-02
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Fredrik Tjernström, Lund University:
Vestibular schwannoma
acoustic neuroma
cerebellopontine angle tumour
gentamicin
rehabilitation
postural balance

Additional relevant MeSH terms:
Neuroma, Acoustic
Neuroma
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action