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

Launched by SIMON JÄGER · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a chemotherapy drug called cisplatin on hearing and balance in patients with head and neck cancer. The main goal is to find out how often inner ear damage happens in these patients and to develop ways to check for it. Researchers will compare two groups of patients: those receiving cisplatin along with radiation therapy and those who are only receiving radiation. Throughout the study, participants will undergo regular tests to assess their hearing and balance before, during, and after treatment. Some may also provide genetic samples to help identify any genes that make them more sensitive to the side effects of cisplatin.

To participate in this study, individuals should be between 18 and 85 years old and have a diagnosis of head and neck squamous cell carcinoma. They must be receiving either cisplatin-based treatment or only radiation therapy. However, those with severe hearing loss, recent balance issues, or certain medical conditions may not be eligible. Participants will be asked to sign a consent form and follow study guidelines, and they will receive regular check-ups to monitor their hearing and balance as part of the trial.

Gender

ALL

Eligibility criteria

• 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