Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT04226456
Status:
TERMINATED
Last Update Posted:
2023-10-24
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081015', 'term': 'Ototoxicity'}, {'id': 'D014012', 'term': 'Tinnitus'}], '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'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparition of ototoxicity', 'timeFrame': '6 month after last injection', 'description': 'the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:\n\n* A Threshold shift of 15 - 25 decibel (dB) averaged at 2 contiguous test frequencies in at least one ear\n* and/or the apparition of a tinnitus (not previously present).'}], 'secondaryOutcomes': [{'measure': 'Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)', 'timeFrame': '6 month after last injection', 'description': 'the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:\n\n* A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear\n* and/or the apparition of a tinnitus (not previously present).'}, {'measure': 'Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA', 'timeFrame': '6 month after last injection', 'description': 'Evaluation of the Impact of Hearing Loss in Adults (ERSA) For each question, the score of 0 means maximal difficulties, the sore of 10 means ideal situation Formulation is uniform, with no inversions: 0 always corresponds to maximal difficulty and 10 to an ideal situation, so that the lower the score the greater the impact of hearing loss on quality of life. Maximum score is 200 for respondents in work and 150 for those not in work or in retirement.'}, {'measure': 'Hearing quality of life: Tinnitus Handicap Index (THI)', 'timeFrame': '6 month after last injection', 'description': 'Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ototoxic Hearing Loss', 'Ototoxic Hearing Loss, Bilateral', 'Ototoxicity', 'Tinnitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.', 'detailedDescription': 'This is a monocentric, randomized, controlled, open label phase IV superiority trial.\n\nAfter signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin).\n\nThe primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18-year-old\n* Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.\n\nExclusion Criteria:\n\n* Women of childbearing potential pregnant or with intention to become pregnant within the trial duration\n* Women who are breastfeeding\n* Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.\n* Conductive hearing loss \\> 20dBHL\n* Meniere disease\n* Medical history of sudden hearing loss\n* Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)'}, 'identificationModule': {'nctId': 'NCT04226456', 'briefTitle': 'Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity', 'orgStudyIdInfo': {'id': 'CHUB-NAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard arm (Arm A): Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease)\n\nDosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.'}, {'type': 'EXPERIMENTAL', 'label': 'N-acetylcysteine', 'description': 'Experimental arm (Arm B):\n\n* 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle.\n* Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease)\n\nDosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.', 'interventionNames': ['Drug: N-acetyl cysteine']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'otherNames': ['Lysomucil 10%'], 'description': 'Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears', 'armGroupLabels': ['N-acetylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Gaëtan Cavelier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Saint Pierre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}