Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02382068
Status:
WITHDRAWN
Last Update Posted:
2017-11-09
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000081015', 'term': 'Ototoxicity'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patients were enrolled to trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)', 'timeFrame': 'Baseline to up to 3 months after completion of cisplatin treatment', 'description': 'Change score will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 month and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.'}], 'secondaryOutcomes': [{'measure': 'Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)', 'timeFrame': 'Baseline to up to 3 months after completion of cisplatin treatment', 'description': 'Will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 months and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.'}, {'measure': 'Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)', 'timeFrame': 'Up to 3 months after completion of cisplatin treatment', 'description': 'Presence or absence of ototoxicity as defined by the ASHA standards for pure tone audiometry (20 dB or greater change at any one test frequency, 10 dB or greater change at any two test frequencies, or any change at any three test frequencies). Analyzed using a repeated measures model and a multi-level model.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malignant Neoplasm', 'Ototoxicity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity.\n\nOUTLINE: Patients are randomized as to which ear receives dexamethasone.\n\nPatients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear.\n\nAfter completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Planned cisplatin treatment restricted to the following treatment course criteria:\n\n * Dose: \\> 50 mg/m\\^2\n * Frequency: every (q)3-q4 weeks\n * Cycles: 7 maximum\n\nExclusion Criteria:\n\n* Previous cisplatin treatment\n* Previous or concurrent radiation treatment to the head and neck region\n* Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery\n* Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)\n* Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)\n* Recent steroid treatment within the last month"}, 'identificationModule': {'nctId': 'NCT02382068', 'briefTitle': 'Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone', 'orgStudyIdInfo': {'id': 'OSU-12003'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01247', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (intratympanic dexamethasone)', 'description': 'Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.', 'interventionNames': ['Drug: Dexamethasone', 'Other: Placebo', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['DM'], 'description': 'Given via intratympanic injection', 'armGroupLabels': ['Supportive care (intratympanic dexamethasone)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given via intratympanic injection', 'armGroupLabels': ['Supportive care (intratympanic dexamethasone)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Platinol'], 'description': 'Standard of care treatment with the following treatment course criteria:\n\n1. Dose: \\> 50 mg/m2\n2. Frequency: q3 -q4 weeks\n3. Cycles: 7 maximum', 'armGroupLabels': ['Supportive care (intratympanic dexamethasone)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aaron Moberly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aaron Moberly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aaron Moberly', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}