Cisplatin-related (Ear) Hearing Loss and Balance Issues in Head and Neck Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll adults with head and neck squamous cell carcinoma and compare two groups: cisplatin-based chemoradiotherapy versus radiotherapy alone. Participants will undergo standardized hearing, balance, and tinnitus assessments at baseline, during treatment, and after treatment. Optional genetic analyses aim to identify genes that may predispose to cisplatin-induced ear damage. The study will help identify how often ear-related side effects occur and how best to screen for them in routine care.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinikum Nuremberg
  Nuremberg, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Prof. Dr. med. Simon Jäger
• Email: simon.jaeger@klinikum-nuernberg.de
• Phone: +49 911-398-2822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.