Status:
NOT_YET_RECRUITING
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Lead Sponsor:
Simon Jäger
Collaborating Sponsors:
Klinikum Nürnberg
Conditions:
Ototoxic Hearing Loss
Ototoxicity, Drug-Induced
Eligibility:
All Genders
18-85 years
Brief 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 chemoradio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06929468
Start Date
July 1 2025
End Date
June 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
Klinikum Nuremberg
Nuremberg, Bavaria, Germany, 90419