[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cisplatin-induced-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cisplatin-induced-hearing-loss":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100587521","cisplatin-induced-cochlear-and-vestibular-damage-in-head-and-neck-cancer-100587521",false,"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","ALL","18 Years","85 Years",{"count":20,"type":21},55,"ESTIMATED","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.",[26,27,28,29,30,31,32,33,34,35,36],"Ototoxic Hearing Loss","Ototoxicity, Drug-Induced","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","NOT_YET_RECRUITING","2025-04-14",{"date":40,"type":41},"2025-04-16","ACTUAL",{"date":43,"type":21},"2025-07",{"date":45,"type":21},"2027-06",{"name":47,"class":48},"Simon Jäger","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100556138","phase-2-acou085-for-hearing-loss-prevention-in-testicular-cancer-patients-receiving-cisplatin-100556138","NCT06521190","ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin","Phase IIa Randomized, Double-blind, and Placebo-controlled Multicenter Split Body Trial of Repeated Doses of ACOU085 for the Prevention of Hearing Loss in Testicular Cancer Patients Receiving Cisplatin","PROHEAR","Inclusion Criteria:\n\n* Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing chemotherapeutic regimen according to current treatment guidelines and site-specific tumor board recommendations\n* Male adult patients at an age between 18 and 45 years\n* Planned cis-Pt treatment with a cumulative dose of ≥300 mg\u002Fm2 which has to be administered in three chemotherapeutic cycles\n* Normal or not clinically relevant otoscopic findings in both ears\n* Normal hearing at both ears according to current WHO criteria for air-conduction 4PTA (0.5\u002F1\u002F2\u002F4 kHz; 0 to 19 dB HL; average of audiometric thresholds at 0.5\u002F1\u002F2\u002F4 kHz) at baseline\n* Normal hearing at both ears according to ASHA criteria with a hearing threshold at any frequency (0.25 to 12 kHz) not exceeding 20 dB and a 4PTA (0.5\u002F1\u002F2\u002F4 kHz) showing ≤15 dB HL at baseline\n* Normal distortion product oto-acoustic emissions (DPOAE) present in both ears at baseline\n* Patient shows normal results at trial start (V1) concerning heart rate (50 to 90 bpm), blood pressure (according to commonly accepted ranges), ECG (no pathological findings), and laboratory parameters (ie, liver and renal function values not clinically significant)\n* Male patients and their female partner(s) must agree to use 2 forms of contraception (one of which must be a barrier method) during 6 months after trial start (V1)\n* Patient is cooperative, able to understand all aspects of the trial, and able to speak German comparable to native speakers as per the investigator's discretion\n* Patient has signed an approved informed consent form indicating that he understands the purpose of and procedures required for the trial, will follow the trial-specific measures, and is willing to participate in the trial\n\nExclusion Criteria:\n\n* Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to KCNQ4)\n* History of middle ear pathology or surgery, otitis externa, chronic otitis media, or recent acute otitis media (within ≤3 months)\n* History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)\n* Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane\n* Hearing loss of \\>45 dB averaged at 6 and 8 kHz in either ear\n* Sudden hearing loss or conductive hearing loss \\>10 dB at two frequencies in either ear\n* Asymmetry in hearing thresholds between left and right ear ≥20 dB at any single frequency or ≥10 dB at any 3 consecutive frequencies ≤ 8 kHz\n* Intake of any ototoxic drugs other than the intended cis-Pt-containing chemotherapeutic drug regimen prior to start of the trial and during the trial period\n* Previous radiation exposure \\>35 Gray to complete or parts of the cochlea\n* Severe concomitant diseases such as heart failure (NYHA II-IV), COPD, bronchial asthma, ongoing malignancies other than testicular cancer, auto-immune or chronic-inflammatory diseases, endocrinological diseases, advanced hepatic or renal failure, and primary complaint of tinnitus\n* Planned consumption of medications, herbal preparations, and specific food ingredients to treat hearing problems and\u002For tinnitus during the trial period\n* Hypersensitivity against any primary or secondary ingredient of IMP\u002FPlacebo medication\n* Male patients with female partners who are pregnant or planning to become pregnant during 6 months after trial start (V1)\n* Use of any other investigational medicinal product (IMP) within five times the half-life of that IMP\u002Frelevant metabolites or one month (whichever is longer) prior to screening and planned use during the trial or up to 30 days after trial completion\n* Patient has any dependent relationship or employment status with respect to the trial site, the sponsor, the investigator, or any supervisor","MALE","45 Years",{"count":61,"type":21},40,"INTERVENTIONAL",[64],"PHASE2","Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.",[28],"RECRUITING","2024-09-03",{"date":70,"type":41},"2024-09-19",{"date":72,"type":41},"2023-12-15",{"date":74,"type":21},"2025-09-30",{"name":76,"class":77},"Acousia Therapeutics GmbH","INDUSTRY",10,"Cisplatin Induced Hearing Loss"]