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Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

Recruitingn/aAges 18 Years - 85 YearsAllSimon Jäger
NCT06929468 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of head and neck squamous cell carcinoma * Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group) * Age 18 to 85 years * Signed agreement and willingness to participate in the study and adhere to the study protocol Exclusion Criteria: * 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) * 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) * Current cochlear implant * Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months * Acute psychosis or serious psychiatric illness * Addiction disorder
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What it tests

  • Not listed
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Where

1 site
Klinikum Nuremberg
Nuremberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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