Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-30 @ 5:08 AM
Study NCT ID:
NCT02415257
Status:
WITHDRAWN
Last Update Posted:
2020-09-11
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences of needed sick-leave from work and leisure activities', 'timeFrame': '6 months after surgery', 'description': 'Time for return to normal daily activities after surgery, both job-related and leisure.'}], 'primaryOutcomes': [{'measure': 'Differences and changes of postural control following surgery, compared to before surgery', 'timeFrame': 'At first vestibular assessment at the time for inclusion and 6 months after surgery', 'description': 'Postural control assessed with posturography during a sensory conflict'}], 'secondaryOutcomes': [{'measure': 'Occurrence of spontaneous nystagmus after surgery', 'timeFrame': 'Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)', 'description': 'To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage'}, {'measure': 'Change of hearing levels', 'timeFrame': 'At first vestibular assessment and 4weeks after gentamicin installation', 'description': 'Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing'}, {'measure': 'Differences in the level of stress after surgery', 'timeFrame': 'Daily after surgery for the duration of the hospital stay, up to 2 weeks', 'description': 'Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital'}, {'measure': 'Differences of subjective well being after surgery', 'timeFrame': 'Immediate time after surgery (2weeks)', 'description': 'Daily subjective assessment of perceived vertigo/dizziness after surgery'}, {'measure': 'Differences of duration of hospital stay', 'timeFrame': 'After surgery for the duration of the hospital stay up to 2 weeks', 'description': 'Length of hospital stay required before patients can be discharged'}, {'measure': 'Differences of subjective well being after gentamicin treatment', 'timeFrame': 'Immediate time after gentamicin treatment (2weeks)', 'description': 'Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment'}, {'measure': 'Differences of perceived dizziness after surgery', 'timeFrame': '6 months after surgery', 'description': 'Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)'}, {'measure': 'Differences of perceived anxiety/depression after surgery', 'timeFrame': '6 months after surgery', 'description': 'Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Change of level of perceived dizziness after surgery as compared to before surgery', 'timeFrame': 'At first vestibular assessment (inclusion) and 6 months after surgery', 'description': 'Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)'}, {'measure': 'Change of level of perceived anxiety/depression after surgery as compared to before surgery', 'timeFrame': 'At first vestibular assessment (inclusion) and 6 months after surgery', 'description': 'Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Differences in vestibular compensation after surgery', 'timeFrame': '6 months after surgery', 'description': 'Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery'}, {'measure': 'Change of vestibular function after gentamicin treatment', 'timeFrame': '6 weeks after gentamicin treatment', 'description': 'Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vestibular schwannoma', 'acoustic neuroma', 'cerebellopontine angle tumour', 'gentamicin', 'rehabilitation', 'postural balance'], 'conditions': ['Vestibular Schwannoma']}, 'referencesModule': {'references': [{'pmid': '18676407', 'type': 'BACKGROUND', '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.'}, {'pmid': '1950529', 'type': 'BACKGROUND', '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."}, {'pmid': '19574236', 'type': 'RESULT', '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.'}, {'pmid': '19645909', 'type': 'RESULT', '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.'}, {'pmid': '22027076', 'type': 'RESULT', '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."}, {'pmid': '17917842', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vestibular schwannoma advised to surgical treatment\n* No measurable remaining vestibular function\n\nExclusion Criteria:\n\n* impaired decision making\n* neurofibromatosis\n* signs for central dysfunction\n* remaining vestibular function\n* Patients are advised not to participate in the gentamicin arm if\n* hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%\n* the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss'}, 'identificationModule': {'nctId': 'NCT02415257', 'briefTitle': 'Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function', 'orgStudyIdInfo': {'id': 'VS-FT-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gentamicin treated', 'description': 'Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery.\n\nRehabilitation 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', 'interventionNames': ['Drug: Gentamicin']}, {'type': 'NO_INTERVENTION', 'label': 'Non-gentamicin', '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'}], 'interventions': [{'name': 'Gentamicin', 'type': 'DRUG', 'otherNames': ['prehabituation'], 'description': 'Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation', 'armGroupLabels': ['Gentamicin treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Fredrik Tjernström, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}