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

Simon Jäger

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma of the Head and Neck; Cisplatin-induced Hearing Loss; Vestibular Disease; Ototoxic Hearing Loss; Hearing Loss; Inner Ear Hearing Loss; Cisplatin Ototoxicity; Dizzyness; Ototoxicity, Drug-Induced; Head and Neck Cancer; Deafness

Study type: Observational

Funder types: Other

Identifiers

NCT06929468

CPN_PMU002

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 2 patient groups

Cisplatin chemoradiotherapy

Description:

Adult patients with head and neck squamous cell carcinoma receiving cisplatin chemotherapy and radiotherapy.

Only radiotherapy

Description:

Adult patients with head and neck squamous cell carcinoma receiving only radiotherapy.