Clinical trial NCT06929468: Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Official title: Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ototoxic Hearing Loss
Ototoxicity, Drug-Induced
Cisplatin-induced Hearing Loss
Cisplatin Ototoxicity
Head and Neck Cancer
Dizzyness
Inner Ear Hearing Loss
Vestibular Disease
Squamous Cell Carcinoma of the Head and Neck
Deafness
Hearing Loss
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Klinikum Nürnberg
First posted: 2025-04-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck squamous cell carcinoma receiving treatment with cisplatin chemoradiotherapy or only radiotherapy at Klinikum Nuremberg in Nuremberg, Germany.

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 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 criteria: 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 outcomes:
measure: Tinnitus
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.
measure: Hearing loss
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
measure: Vestibular dysfunction
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Secondary outcomes:
measure: Description of hearing loss through further testing
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
measure: Description of vestibular damage manifesting as worsening dizzyness or imbalance during treatment with cisplatin
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
measure: Description of the incidence and type of cisplatin dose-limiting toxicities
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
measure: Assessment of tumour-related quality of life
timeFrame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Other outcomes:
measure: Genetic variants related to cisplatin-induced ototoxicity
timeFrame: Once-off blood sample taken simultaneously with any of the routine blood samples during treatment, can be at any point from study enrollment to the last follow-up visit circa 3 months after treatment completion.
Locations:
city: Nuremberg
country: Germany
facility: Klinikum Nuremberg
state: Bavaria
Study officials:
References: