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NCT06929468 | NOT YET RECRUITING | Ototoxic Hearing Loss

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

Simon Jäger

Information provided by (Responsible Party):

Simon Jäger

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.

Condition or disease

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 55 participants
Official Title : Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

Location Details

NCT06929468

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How to Participate

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Locations

Not yet recruiting

Germany, Bavaria

Clinic Nuremberg

Nuremberg, Bavaria, Germany, 90419