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Vestibular SchwannomaPhase 4NCT02379754

Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

A Phase 4 study testing Gentamicins in people with Vestibular Schwannoma, run by Lund University at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vestibular Schwannoma
What is being tested?
Gentamicins
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSweden
Study dates
Jan 2015to Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed with vestibular schwannoma and surgical treatment is advised
  • remaining vestibular function

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

    Lund, 22185

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Gentamicins
Keywords
vestibular schwannoma, acoustic neuroma, cerebellopontine angle tumour, gentamicin, rehabilitation, postural balance
Medical subject headings
Neuroma, Acoustic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GentamicinsDrug

    Also called Prehabituation, PREHAB, Intratympanic installation of gentamicin

    Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Study groups in NCT02379754
Study groupRoleWhat they receive
Gentamicin treatedExperimentalInstallation 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.
Receives: Drug: Gentamicins
Non-gentamicinNo interventionRehabilitation 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences and changes of postural control following surgery, compared to before surgery

    Postural control assessed with posturography during a sensory conflict

    Measured: At first vestibular assessment at the time for inclusion and 6 months after surgery

Secondary outcomes (12)

  1. Differences of duration of hospital stay

    Hospital stay required before patients can be discharged

    Measured: After surgery for the duration of the hospital stay up to two weeks

  2. Differences of subjective well being after surgery

    Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment

    Measured: Immediate time after surgery (2 weeks)

  3. Change of subjective well being after gentamicin treatment

    Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment

    Measured: Immediate time after gentamicin installation (2 weeks)

  4. Change of hearing levels

    Measuring hearing levels (pure tone hearing and speech discrimination) before and after gentamicin treatment to determine possible detrimental effect on hearing

    Measured: At first vestibular assessment and 2 weeks after gentamicin installation

  5. Differences in the level of stress after surgery

    Daily Measures of cortisol in the saliva after surgery during the time patients are admitted to the hospital

    Measured: Daily after surgery for the duration of the hospital stay up to 2 weeks

  6. Differences of perceived dizziness after surgery

    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

    Measured: 6 months after surgery

  7. Differences of level of anxiety and depression

    Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)

    Measured: 6 months after surgery

  8. Change of level of perceived dizziness after gentamicin

    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

    Measured: At first vestibular assessment and 6 weeks after gentamicin installation

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

    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)

    Measured: At first vestibular assessment and 6 months after surgery

  10. Occurrence of spontaneous nystagmus after surgery

    To measure spontaneous nystagmus after surgery and its direction as a sign of vestibular deafferentation or central nervous damage

    Measured: Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)

  11. Differences in vestibular compensation after surgery

    Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation after surgery

    Measured: 6 months after surgery

  12. Change of vestibular function after gentamicin treatment

    Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation and function after gentamicin treatment

    Measured: 6weeks after gentamicin treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2019
  4. Study completionSep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379754
Sponsor's protocol ID
VS-FT-01
Status last verified
Sep 2020
First submitted
25 Jan 2015
Last updated
11 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 1950529

  • 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.

    PubMed 19574236

  • 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.

    PubMed 19645909

  • 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.

    PubMed 22027076

  • 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.

    PubMed 17917842

  • Postema RJ, Kingma CM, Wit HP, Albers FW, Van Der Laan BF. Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial. Acta Otolaryngol. 2008 Aug;128(8):876-80. doi: 10.1080/00016480701762458.

    PubMed 18607963

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gentamicins in people with Vestibular Schwannoma, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379754, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.

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