Clinical trial · Observational
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cisplatin-induced Hearing Loss | — | UNRESOLVED | — |
| Cisplatin Ototoxicity | — | UNRESOLVED | — |
| Deafness | — | UNRESOLVED | — |
| Dizzyness | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hearing Loss | — | UNRESOLVED | — |
| Inner Ear Hearing Loss | — | UNRESOLVED | — |
| Ototoxic Hearing Loss | — | UNRESOLVED | — |
| Ototoxicity, Drug-Induced | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cisplatin chemoradiotherapy
- description
- Adult patients with head and neck squamous cell carcinoma receiving cisplatin chemotherapy and radiotherapy.
- label
- Only radiotherapy
- description
- Adult patients with head and neck squamous cell carcinoma receiving only radiotherapy.
Primary outcomes (3)
- measure
- Tinnitus
- timeFrame
- From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.
- description
- 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.
- measure
- Hearing loss
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available