Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

NCT02379754 | Withdrawn Phase 4

• 1 other identifier: VS-FT-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

vestibular schwannoma; acoustic neuroma; cerebellopontine angle tumour; gentamicin; rehabilitation; postural balance

Outcome Measures

Primary Outcomes (1)

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

  Postural control assessed with posturography during a sensory conflict

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

Secondary Outcomes (12)

• Differences of duration of hospital stay

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

• Differences of subjective well being after surgery

  Immediate time after surgery (2 weeks)

• Change of subjective well being after gentamicin treatment

  Immediate time after gentamicin installation (2 weeks)

• Change of hearing levels

  At first vestibular assessment and 2 weeks after gentamicin installation

• Differences in the level of stress after surgery

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

Other Outcomes (1)

• Differences of needed sick-leave from work and leisure activities

  6 months after surgery

Study Arms (2)

Gentamicin treated

EXPERIMENTAL

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

Non-gentamicin

NO INTERVENTION

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.

Interventions

Gentamicins DRUG

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

Also known as: Prehabituation, PREHAB, Intratympanic installation of gentamicin

Gentamicin treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, 22185, Sweden

Location

Related Publications (6)

• 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.

  PMID: 1950529 BACKGROUND

• 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.

  PMID: 19574236 RESULT

• 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.

  PMID: 19645909 RESULT

• 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.

  PMID: 22027076 RESULT

• 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.

  PMID: 17917842 RESULT

• 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.

  PMID: 18607963 RESULT

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; 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

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Fredrik Tjernström, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

SE (1)