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Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

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ClinicalTrials.gov Identifier: NCT02379754
Recruitment Status : Recruiting
First Posted : March 5, 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 remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

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

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.

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 Definite Remaining Vestibular Function
Study Start Date : January 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2018


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: Gentamicins
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
Other Names:
  • Prehabituation, PREHAB
  • Intratympanic installation of gentamicin

No Intervention: Non-gentamicin
Rehabilitation exercises before and after 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. Differences of duration of hospital stay [ Time Frame: After surgery for the duration of the hospital stay up to two weeks ]
    Hospital stay required before patients can be discharged

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

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

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

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

  6. Differences of perceived dizziness after surgery [ Time Frame: 6 months after surgery ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

  7. Differences of level of anxiety and depression [ Time Frame: 6 months after surgery ]
    Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)

  8. Change of level of perceived dizziness after gentamicin [ Time Frame: At first vestibular assessment and 6 weeks after gentamicin installation ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

  9. Differences of changes in levels of perceived dizziness after surgery as compared to before surgery [ Time Frame: At first vestibular assessment and 6 months after surgery ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

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

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

  12. Change of vestibular function after gentamicin treatment [ Time Frame: 6weeks after gentamicin treatment ]
    Vestibular function tests, v-HIT, 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 to return to normal daily activities after surgery, both job-related and leisure activities



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

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): NCT02379754


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    +4646 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: NCT02379754     History of Changes
Other Study ID Numbers: VS-FT-01
First Posted: March 5, 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