Not Yet RecruitingNot Applicable

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

Germany55 participantsStarted 2025-07

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tinnitus

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.

Hearing loss

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.

Vestibular dysfunction

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.

Trial details

NCT IDNCT06929468

SponsorSimon Jäger

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

Contact for this trial

Prof. Dr. med. Simon Jäger

+49 911-398-2822 simon.jaeger@klinikum-nuernberg.de

View on ClinicalTrials.gov More Ototoxic Hearing Loss trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Tinnitus

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.

Hearing loss

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.

Vestibular dysfunction

Timeframe: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.