[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ototoxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ototoxicity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100620986","phase-2-protective-effect-of-acetylcysteine-against-cisplatinum-induced-ototoxicity-a-randomized-controlled-trial-100620986",false,"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.","ALL","18 Years","70 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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).",[26,27,28,29],"Cisplatin-induced Ototoxicity","Sensorineural Hearing Loss","Ototoxicity","Ototoxicity, Drug-Induced",[26,27,28],"RECRUITING","2026-01-16",{"date":34,"type":35},"2026-01-23","ACTUAL",{"date":37,"type":35},"2024-12-23",{"date":39,"type":20},"2027-03-31",{"name":41,"class":42},"Siriraj Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100488540","radiosurgery-induced-ototoxicity-in-patients-treated-for-a-vestibular-schwannoma-100488540","NCT05641441","Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma","Inclusion Criteria:\n\n* Aged 18 years or above\n* Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study\n* Patients willing to take part in the study and give their informed consent\n\nExclusion Criteria:\n\n* Previous surgical or radiation therapy for VS (including SRS)\n* Patients diagnosed with neurofibromatosis type II\n* Preexisting profound hearing loss, with a pure tone average (PTA) \\>90 and word recognition score (WRS) \\\u003C10%, upon initial assessment\n* Previous middle ear surgery of the affected ear\n* Concurrent treatment with other experimental drugs",{"count":51,"type":20},258,"OBSERVATIONAL","The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated.\n\nAdditionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.",[55,28],"Vestibular Schwannoma",[57,28,55,58,59],"Radiosurgery","Hearing loss","Quality of Life","2025-01-09",{"date":62,"type":35},"2025-01-13",{"date":64,"type":35},"2023-01-24",{"date":66,"type":20},"2030-11-15",{"name":68,"class":42},"University Hospital, Geneva",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100322673","phase-2-treatment-of-radiation-and-cisplatin-induced-toxicities-with-tempol-100322673","NCT03480971","Treatment of Radiation and Cisplatin Induced Toxicities with Tempol","A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy","Inclusion Criteria:\n\n1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);\n2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;\n3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;\n4. If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study;\n5. Must be receiving cisplatin for chemotherapy;\n6. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;\n7. Must have a score 2 or less on the ECOG performance status;\n8. Participant life expectancy ≥ 6 months; and\n9. Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):\n\nHaematology:\n\nAbsolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g\u002FdL Platelets ≥ 100,000 per microliter of blood\n\nHepatic:\n\nTotal bilirubin ≤ 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ≤5 x ULN\n\nRenal:\n\nSerum creatinine ≤ ULN or, if \\> ULN calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin.\n\nNutritional and metabolic:\n\nUrine Albumin \\\u003C 3.0 mg\u002Fdl\n\nExclusion Criteria:\n\n1. Prior radiotherapy of the head and neck;\n2. Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment;\n3. Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;\n4. Be taking mugard;\n5. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;\n6. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;\n7. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;\n8. Have used an investigational drug within 28 days of the initiation of study treatment;\n9. Have a history of a positive blood test for HIV;\n10. At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;\n11. Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;\n12. Participants with body weight less than 35 kg, 77 lbs;\n13. Women who are pregnant or who are breastfeeding;\n14. Participants with known intolerance to platin drugs;\n15. History of insulin-dependent Diabetes Mellitus; and\n16. Participants with Hepatitis B\u002FC.",{"count":77,"type":20},120,[23],"A 10 week trial to assess the ability of Tempol to prevent and\u002For reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.",[81,82,28],"Mucositis","Nephrotoxicity",[84],"cisplatin toxicity","2024-11-18",{"date":87,"type":35},"2024-11-20",{"date":89,"type":35},"2019-05-13",{"date":91,"type":20},"2025-12",{"name":93,"class":94},"Matrix Biomed, Inc.","INDUSTRY",9]