[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511176":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":24,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Institut de Cancérologie de Lorraine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients suffering from chemotherapy-induced ototoxicity","ACTIVE_COMPARATOR","Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.",[13],"Other: Patients suffering from chemotherapy-induced ototoxicity",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids","EXPERIMENTAL","Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.",[19],"Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"At baseline,\n\n* medical staff carries out a clinical and audiometric and\u002For 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\u002For 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.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"At baseline,\n\n* medical staff carries out a clinical and audiometric and\u002For 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\u002For 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.",[15],[29],{"name":30,"affiliation":5,"role":31},"ROMINA MASTRONICOLA, MD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"JEAN LOUIS MERLIN, PUPH","CONTACT","+33 3 83 65 60 62","jl.merlin@nancy.unicancer.fr",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"CECILE HUIN SCHOHN, PhD","+33 3 83 59 86 07","c.huinschohn@nancy.unicancer.fr",[43],{"facility":44,"status":45,"city":46,"state":24,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Institut de Cancerologie de Lorraine","RECRUITING","Vandœuvre-lès-Nancy","54500","France","FR",{"type":51,"coordinates":52},"Point",[53,54],6.17114,48.66115,{"lat":54,"lon":53},[57,59,60],{"name":58,"role":35,"phone":36,"phoneExt":24,"email":37},"JEAN LOUIS MERLIN, MD",{"name":39,"role":35,"phone":24,"phoneExt":24,"email":41},{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":62,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100511176","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-100511176",false,"NCT05936034","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.","PROTOTOX","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","ALL","18 Years",{"count":73,"type":74},52,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.",[80,81,82,83],"Cancer","Ototoxicity, Drug-Induced","Quality of Life","Hearing Disorders","2025-11-21",{"date":86,"type":87},"2025-11-28","ACTUAL",{"date":89,"type":87},"2024-01-04",{"date":91,"type":74},"2028-07-04",{"name":5,"class":6},1]