Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT05936034
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000081015', 'term': 'Ototoxicity'}, {'id': 'D006311', 'term': 'Hearing Disorders'}], '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': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life of patients', 'timeFrame': '6 months', 'description': 'The quality of life of patients with hearing aids suffering from ototoxicity due to platinum-based chemotherapy will be assessed using the 36 Item Short-Form Health Survey (SF36).\n\n\\[score 0 to 100 : score 0 representing the lowest possible scores and score 100 representing the highest possible scores. A higher score means better health.'}], 'secondaryOutcomes': [{'measure': 'Measuring hearing and the onset of tinnitus in patients', 'timeFrame': '6 months', 'description': 'Hearing and the onset of tinnitus in hearing-aided patients suffering from chemotherapy-induced ototoxicity will be assessed by Hertz/Decibel measurement using an audiometer'}, {'measure': 'Patient compliance to wearing a hearing aid', 'timeFrame': '6 months', 'description': 'Hearing aid compliance will be assessed according to the proportion of patients completing 6-month follow-up with a hearing aid among all included patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Ototoxicity, Drug-Induced', 'Quality of Life', 'Hearing Disorders']}, 'descriptionModule': {'briefSummary': "There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a the French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis.\n\nImproving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments but none has led to a consensus on management.\n\nThe aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient currently undergoing treatment with platinum-based chemotherapy and suffering from hypoacusia consistent with the treatment or presenting a worsening of already existing hypoacusis consistent with the start of treatment with platinum-based chemotherapy\n* Patient whose hypoacusis is confirmed by the audiometric test\n* Patient able and willing to follow all study procedures in accordance with the protocol.\n* Patient having understood, signed and dated the consent form\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Persons deprived of liberty or under guardianship (including curatorship)\n* Impossibility of submitting to medical monitoring of the trial for geographical, social or psychological reasons\n* Patient with a contraindication to wearing hearing aids\n* Patient already fitted\n* Patient already included in a protocol including an experimental molecule\n* Patient who has not started treatment with platinum-based chemotherapy\n* Patient presenting only tinnitus without hearing loss'}, 'identificationModule': {'nctId': 'NCT05936034', 'acronym': 'PROTOTOX', 'briefTitle': 'Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.', 'orgStudyIdInfo': {'id': '2023-A02141-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients suffering from chemotherapy-induced ototoxicity', 'description': 'Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.', 'interventionNames': ['Other: Patients suffering from chemotherapy-induced ototoxicity']}, {'type': 'EXPERIMENTAL', 'label': 'Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids', 'description': 'Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.', 'interventionNames': ['Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids']}], 'interventions': [{'name': 'Patients suffering from chemotherapy-induced ototoxicity', 'type': 'OTHER', 'description': 'At baseline,\n\n* medical staff carries out a clinical and audiometric and/or tintometric examination\n* patient completes the SF36 survey (36 Item Short-Form Health Survey)\n* Patients will then be randomized to either:\n\n * Control group: standard support; Once the patient has been fit, he continues his carcinological treatment with platinum-based chemotherapy according to the recommendations specific to his pathology.\n\nAt one, three and six months after fitting,\n\n* medical staff carries out a clinical examination\n* This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire.\n\nOnly at the last visit (6 months) all patients included should complete a satisfaction questionnaire.', 'armGroupLabels': ['Patients suffering from chemotherapy-induced ototoxicity']}, {'name': 'Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids', 'type': 'OTHER', 'description': 'At baseline,\n\n* medical staff carries out a clinical and audiometric and/or tintometric examination\n* patient completes the SF36 survey (36 Item Short-Form Health Survey)\n* Patients will then be randomized to either:\n\n * Experimental group: standard treatment with hearing aids (wearing a hearing aid).\n\nOnce the patient has been fit, he continues his carcinological treatment with platinum-based chemotherapy according to the recommendations specific to his pathology.\n\nAt one, three and six months after fitting,\n\n* medical staff carries out a clinical examination\n* This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire.\n\nOnly at the last visit (6 months) all patients included should complete a satisfaction questionnaire.', 'armGroupLabels': ['Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JEAN LOUIS MERLIN, MD', 'role': 'CONTACT', 'email': 'jl.merlin@nancy.unicancer.fr', 'phone': '+33 3 83 65 60 62'}, {'name': 'CECILE HUIN SCHOHN, PhD', 'role': 'CONTACT', 'email': 'c.huinschohn@nancy.unicancer.fr'}, {'name': 'ROMINA MASTRONICOLA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Cancerologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'JEAN LOUIS MERLIN, PUPH', 'role': 'CONTACT', 'email': 'jl.merlin@nancy.unicancer.fr', 'phone': '+33 3 83 65 60 62'}, {'name': 'CECILE HUIN SCHOHN, PhD', 'role': 'CONTACT', 'email': 'c.huinschohn@nancy.unicancer.fr', 'phone': '+33 3 83 59 86 07'}], 'overallOfficials': [{'name': 'ROMINA MASTRONICOLA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}