Ototoxic Hearing LossOtotoxicity, Drug-InducedCisplatin-induced Hearing LossCisplatin OtotoxicityHead and Neck CancerDizzynessInner Ear Hearing LossVestibular DiseaseSquamous Cell Carcinoma of the Head and NeckDeafnessHearing Loss
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Tinnitus — From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment. 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.
Hearing loss — From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion. 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.
Vestibular dysfunction — From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion. Incidence of dizziness or balance disturbances during treatment with cisplatin chemotherapy as determined through the Dizziness Handicap Inventory (DHI); changes of \>18 indicates a clinical relevant worsening in condition:
0-29 = no to mild impairment. 30-60 = moderate impairment. \>60 = severe impairment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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