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

N/ANot Yet RecruitingNCT06929468

Simon Jäger55 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ototoxic Hearing Loss Ototoxicity, Drug-Induced Cisplatin-induced Hearing Loss Cisplatin Ototoxicity Head and Neck Cancer Dizzyness Inner Ear Hearing Loss

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tinnitus

Incidence and severity of new or exacerbated tinnitus during treatment with cisplatin chemotherapy measured as impairment according to the Tinnitus Handicap Inventory (THI) score: 0-16 = no impairment. 18-36 = mild impairment. 38-56 = moderate impairment. 58-76 = severe impairment. 78-100 = catastrophic impairment.

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

Hearing loss

Incidence of significant hearing loss during treatment with cisplatin chemotherapy described according to CTCAE (Common Terminology Criteria for Adverse Events) in 1-8 kHz audiogram: Grade 1 = threshold shift 15-25 dB in 2 contiguous test frequencies in at least one ear. Grade 2 = threshold shift \>25 dB in 2 contiguous test frequencies in at least one ear. Grade 3 = threshold shift of \>25 dB averaged at 3 contiguous test frequencies in at least one ear. Grade 4 = decrease in hearing to profound bilateral loss, absolute threshold \>80 dB at 2 kHz and above.