Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-01 @ 4:29 PM
Study NCT ID:
NCT04214769
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001299', 'term': 'Audiometry'}, {'id': 'D000158', 'term': 'Acoustic Impedance Tests'}, {'id': 'D004584', 'term': 'Electronystagmography'}], 'ancestors': [{'id': 'D006320', 'term': 'Hearing Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D053483', 'term': 'Eye Movement Measurements'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D014724', 'term': 'Vestibular Function Tests'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-28', 'studyFirstSubmitDate': '2019-12-28', 'studyFirstSubmitQcDate': '2019-12-28', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Audiometry', 'timeFrame': '1.5 Year', 'description': 'The change in hearing threshold and in the speech-audiometry'}, {'measure': 'ENG test', 'timeFrame': '1.5 Year', 'description': 'Abnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance'}, {'measure': 'VEMP test', 'timeFrame': '1.5 Year', 'description': 'Abnormal latencies, amplitudes, thresholds'}, {'measure': 'vHIT test', 'timeFrame': '1.5 Year', 'description': 'abnormal gain, the appearance of overt and covert saccades'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer Patients Treated With Radiotherapy']}, 'descriptionModule': {'briefSummary': 'Aims: 1. To evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (Audiometry and tympanometry, vHIT, VEMP, ENG) ; 2. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females and males, Age: ≥ 18 years old\n* Patients diagnosed Head and Neck cancers, not treated previously\n* Planned for radiation therapy in which the inner ear will be radiated\n\nExclusion Criteria:\n\n* Patients who were previously diagnosed with a vestibular disorder\n* Previous middle or inner ear anomaly\n* Failure to complete the whole course of radiation therapy\n* More than one course of radiation therapy\n* Patients treated with concurrent ototoxic chemotherapy\n* Pregnant women\n* Patients who will not sign an informed consent form\n* Helpless or incompetent patients'}, 'identificationModule': {'nctId': 'NCT04214769', 'briefTitle': 'Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Evaluation of the Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function Using Novel Techniques', 'orgStudyIdInfo': {'id': '403-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Head and Neck Cancer patients', 'interventionNames': ['Diagnostic Test: Audiometry and tympanometry, vHIT, VEMP, ENG']}], 'interventions': [{'name': 'Audiometry and tympanometry, vHIT, VEMP, ENG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic tests', 'armGroupLabels': ['Head and Neck Cancer patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yahav Oron, MD', 'role': 'CONTACT', 'email': 'oron.yahav@gmail.com', 'phone': '973236973573'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}