[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ototoxicity-drug-induced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ototoxicity-drug-induced":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,72,97,123,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100495369","phase-2-prevention-of-ototoxicity-in-ntm-patients-treated-with-iv-amikacin-100495369",false,"NCT05730283","Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin","Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Non-Tuberculous Mycobacterium Disease","Inclusion Criteria:\n\n1. Providing informed consent, documented by signing and dating the currently valid informed consent form.\n2. Considered by the Investigator to have unimpaired consent capacity, without reliance on a legally authorized representative.\n3. Stated willingness and ability to comply with study procedures and availability for the duration of the study.\n4. Aged \\> 18 and \\\u003C 80.\n5. NTM infection meeting current Pulmonary NTM guidelines from the American Thoracic Society and the Infectious Diseases Society of America (ATS\u002FIDSA) for systemic (IV) aminoglycoside therapy.\n6. Anticipated duration of IV amikacin treatment of at least 30 days at time of study entry.\n7. Statement of ability to take oral medication and adhere to the daily dosing regimen.\n8. For females of reproductive potential: If they are of childbearing potential, they must agree in writing to practice an effective double barrier method of contraception from the signing of the informed consent form until 1 month following discontinuation of study drug treatment or agree to practice true abstinence, when this is consistent with the preferred and usual lifestyle of the subject.\n9. For males of reproductive potential: Agree to practice effective barrier contraception from the signing of the informed consent form until 3 months (one spermatogenesis cycle) following the last dose of study drug or agree to practice true abstinence.\n\nExclusion Criteria:\n\n1. Received a systemic aminoglycoside antibiotic within 6 months prior to planned first dose of amikacin.\n2. ECG at Screening or prior to randomization (mean of triplicate values) with QT interval corrected using Fridericia's formula (QTcF interval) ≥ 450 msec.\n3. ECG at Screening or prior to randomization with abnormalities that, in the Investigator's judgment, might predispose patient to clinically significant arrhythmia.\n4. Patients taking strong CYP3A4 inducers such as rifampin and rifabutin in the 7 days prior to randomization or have the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inducers during the study. If an additional antibiotic is needed, then azithromycin will be used.\n5. Patients taking strong CYP3A4 inhibitors such as clarithromycin in the 7 days prior to randomization or the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inhibitors during the study. If an additional antibiotic is needed, then azithromycin will be used.\n6. Patients taking clofazimine or bedaquiline AND who also have congestive heart failure, significant ventricular arrhythmia, uncorrected hypokalemia, or ECG (single at Screening, mean of triplicate prior to randomization) showing QRS \\> 120 msec or heart rate \\\u003C 50 bpm.\n7. Patients with amikacin exposure within the 6 months prior to randomization.\n8. Patients with known amikacin resistance (MIC \\>64)\n9. Progressive liver disease (Child-Pugh B or C) which would affect or invalidate interpretation of change from the baseline liver function tests over the course of the study.\n10. Signs of disturbed integrity of the tympanic membrane, determined by otoscopy or tympanometry, including chronic perforation or middle ear or ear canal inflammation or effusion.\n11. History of congenital hearing loss, otological surgery (excluding myringotomy tubes or simple tympanoplasty healed and currently intact), sudden hearing loss, or Meniere's disease.\n12. Bilateral profound hearing loss (\\>90 Decibels \\[dB\\] HL) at all test frequencies.\n13. Conductive hearing loss evidenced by average air-bone-gaps \\>15 dB HL for 0.25-4.0 kilohertz (kHz)\n14. History of active malignancy, either untreated or under active treatment.\n15. History of risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n16. Venous access not adequate for performance of study procedures.\n17. Presence of any circumstance, condition, ECG or laboratory finding that, based on investigator judgment, would interfere with study procedures or assessments or present to the patient an unreasonable risk from participation in this study.\n18. Current or anticipated use of excluded concomitant medications as specified in Section 6.5.\n19. Pregnant or lactating.\n20. Female of childbearing potential who does not have a negative serum pregnancy test and does not agree in writing to using a double barrier method of contraception.\n21. Female relying on menopausal status for contraception who does not have Follicle-Stimulating Hormone (FSH) level consistent with that condition and who does not agree in writing to using a double barrier method of contraception.\n22. Currently under correctional supervision (imprisoned, on probation or parole).","ALL","18 Years","80 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is:\n\n* Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment?\n* Is ORC-13661 effective for preventing or lessening other measures of hearing impairment?\n\nParticipants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health.\n\nResearchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.",[27],"Ototoxicity, Drug-Induced",[29,30,31,32],"NTM","nontuberculous mycobacteria","ototoxicity","hearing loss","RECRUITING","2026-05-05",{"date":36,"type":37},"2026-05-07","ACTUAL",{"date":39,"type":37},"2025-06-02",{"date":41,"type":21},"2028-02-29",{"name":43,"class":44},"Kevin Winthrop","OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100620986","phase-2-protective-effect-of-acetylcysteine-against-cisplatinum-induced-ototoxicity-a-randomized-controlled-trial-100620986","NCT07364747","Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* Patients scheduled to receive high-dose cisplatin-based chemotherapy regimens with a projected cumulative cisplatin dose of \\> 200 mg\u002Fm2 and each dose \\> 50 mg\u002Fm2\n* Patients may receive concurrent chemotherapy with non-ototoxic agents\n* Patients may receive concurrent radiation therapy to the skull base, provided the radiation dose does not exceed the toxic threshold for ototoxicity\n* Patients receiving an appropriate antiemetic regimen consisting of Olanzapine or Neurokinin-1 (NK1) receptor antagonists\n* Patients receiving medical treatment at Siriraj Hospital.\n\nExclusion Criteria:\n\n* Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx).\n* Patients with a history of head and neck radiation therapy where the radiation dose to the cochlea exceeded 9 Gy or the dose to the eustachian tube exceeded 50 Gy on both sides.\n* Patients who have received N-acetylcysteine (NAC) within 2 weeks prior to the start of the study.\n* Patients who have received other ototoxic drugs within 2 weeks prior to or during the study, including but not limited to:\n\nAminoglycoside antibiotics, Vancomycin, Loop diuretics (e.g., Furosemide), High-dose Aspirin, Antimalarial drugs (e.g., Quinine)\n\n\\- Patient with a known allergy or hypersensitivity to acetylcysteine.","70 Years",{"count":54,"type":21},40,[24],"The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).",[58,59,60,27],"Cisplatin-induced Ototoxicity","Sensorineural Hearing Loss","Ototoxicity",[58,59,60],"2026-01-16",{"date":64,"type":37},"2026-01-23",{"date":66,"type":37},"2024-12-23",{"date":68,"type":21},"2027-03-31",{"name":70,"class":44},"Siriraj Hospital",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"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","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",{"count":80,"type":21},52,[82],"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.",[85,27,86,87],"Cancer","Quality of Life","Hearing Disorders","2025-11-21",{"date":90,"type":37},"2025-11-28",{"date":92,"type":37},"2024-01-04",{"date":94,"type":21},"2028-07-04",{"name":96,"class":44},"Institut de Cancérologie de Lorraine",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100589647","analysis-of-risk-factors-for-hearing-loss-in-survivors-of-cancer-occurred-during-childhood-adolescence-or-young-adulthood-100589647","NCT06957132","Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood","RISP-OTOTOX","Inclusion Criteria:\n\n* Patients aged between 18 and 50 years at audiological investigations\n* Treated for brain tumor, solid cancer, lymphoma or leukemia in childhood, adolescence or at a young adult age (\\\u003C25years)\n* With at least 5 years of cancer-free follow-up after childhood cancer\n* Patients included in the FCCSS ( https:\u002F\u002Ffccss.fr ) deep cohort of 7670 5-year childhood cancer survivors treated before 2001, or patients who have planned visit in long-term follow-up clinics of Curie Institute and Gustave Roussy, whatever the diagnostic period\n* Pregnant or breast-feeding women can be included as no risk is identified\n* With Social security coverage\n* Signed written informed consent obtained\n\nNB: Patients included in another research project are not excluded from this one\n\nNB: patients wearing a Lyric hearing prosthesis or any other permanent hearing prosthesis or cochlear implant can be included in the study but will not perform audiological examinations because the audiogram can't be easily performed without hearing prosthesis. Nevertheless, these patients could participate to the study with self-administered questionnaires and could be included as cases (i.e. patients with hearing deficiency) in analyses.\n\nExclusion Criteria:\n\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n* Patient with unavailable data concerning treatment modalities including cumulative doses of chemotherapy agents or radiation fields and dose","50 Years",{"count":106,"type":21},500,[82],"This study is aimed at people treated for cancer before the age of 25, who have been followed for at least 5 years, and who are now aged between 18 and 50. It is a prospective, multicenter, non-randomized study.\n\nThe main aim of the project is to identify hearing impaired patients using the iAudiogram medical device, and to analyze the risk factors associated with the risk of hearing impairment.\n\nAround 500 patients will take part in this study in France. Participation in this research project will consist in carrying out a hearing test (audiogram with tonal audiometry) with the iAudigram medical device (at Gustave Roussy, Curie or Necker Hospital) and completing self-questionnaires focusing on ototoxicity and its consequences.",[27,110,111],"Ototoxicity, Radiation-Induced","Pediatric Cancer","NOT_YET_RECRUITING","2025-04-25",{"date":115,"type":37},"2025-05-04",{"date":117,"type":21},"2025-05",{"date":119,"type":21},"2026-04",{"name":121,"class":44},"Gustave Roussy, Cancer Campus, Grand Paris",3,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":133,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":71},"100587521","cisplatin-induced-cochlear-and-vestibular-damage-in-head-and-neck-cancer-100587521","NCT06929468","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study","Inclusion Criteria:\n\n* Diagnosis of head and neck squamous cell carcinoma\n* Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group)\n* Age 18 to 85 years\n* Signed agreement and willingness to participate in the study and adhere to the study protocol\n\nExclusion Criteria:\n\n* Severe hearing impairment (WHO grade 3 or 4, corresponding to an audiometric ISO value of ≥61 dB in the better ear at frequencies of 500, 1000, 2000 and 4000 Hz)\n* Self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study)\n* Current cochlear implant\n* Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months\n* Acute psychosis or serious psychiatric illness\n* Addiction disorder","85 Years",{"count":132,"type":21},55,"6 Months","OBSERVATIONAL","The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.",[137,27,138,139,140,141,142,143,144,145,146],"Ototoxic Hearing Loss","Cisplatin-induced Hearing Loss","Cisplatin Ototoxicity","Head and Neck Cancer","Dizzyness","Inner Ear Hearing Loss","Vestibular Disease","Squamous Cell Carcinoma of the Head and Neck","Deafness","Hearing Loss","2025-04-14",{"date":149,"type":37},"2025-04-16",{"date":151,"type":21},"2025-07",{"date":153,"type":21},"2027-06",{"name":155,"class":44},"Simon Jäger",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":134,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":71},"100553741","diagnostic-of-various-ototoxicity-induced-by-cancer-treatment-100553741","NCT06490029","Diagnostic of Various Ototoxicity Induced by Cancer Treatment","Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments","BIO-OTOTOX","Inclusion Criteria:\n\n* Age 18 and over\n* Registered with social security\n* Signed consents\n* Absence of presbycusis prior to cancer treatment (groups A and C)\n* No known presbycusis (group B)\n* Previous exposure to an ototoxic\u002Fneurotoxic agent (group A)\n* Indication for initiation of ototoxic\u002Fneurotoxic therapy (group C)\n\nExclusion Criteria:\n\n* \\- Subjects deprived of liberty\n* Subjects unable to read or write the French language\n* Pregnant and breast-feeding women\n* Previous treatment for ototoxicity\n* History of bilateral auditory pathology, in particular otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma.\n* History of severe head trauma (Glasgow Coma Score \\\u003C= 8)\n* Abnormal otoscopy or tympanometry In addition for group B\n* Previous chemotherapy\n* Previous ENT radiotherapy\n* Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy",true,{"count":166,"type":21},540,"39 Months","• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex\u002Fgender, age, medical condition (cancer patients treated with surgery alone and\u002For radiotherapy and\u002For chemotherapy, and healthy volunteers).\n\nThe main question it aims to answer is:\n\n• To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures.\n\nParticipants will be studied:\n\nEither only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition)\n\nParticipants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)",[27],"2024-06-28",{"date":172,"type":37},"2024-07-08",{"date":174,"type":37},"2024-06-19",{"date":176,"type":21},"2027-09-19",{"name":178,"class":44},"Direction Centrale du Service de Santé des Armées"]