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Not yet recruiting NCT06929468

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

— Observational Ototoxic Hearing Loss Ototoxicity, Drug-Induced Cisplatin-induced Hearing Loss Cisplatin Ototoxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ototoxic Hearing Loss, Ototoxicity, Drug-Induced, Cisplatin-induced Hearing Loss, Cisplatin Ototoxicity. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study

Overview

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.

Primary outcome measures

  • Tinnitus [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.]
  • Hearing loss [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]
  • Vestibular dysfunction [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]
Secondary outcome measures (4)
  • Description of hearing loss through further testing [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]
  • Description of vestibular damage manifesting as worsening dizzyness or imbalance during treatment with cisplatin [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]
  • Description of the incidence and type of cisplatin dose-limiting toxicities [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]
  • Assessment of tumour-related quality of life [Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Klinikum Nuremberg — Nuremberg

Identifiers

NCT: NCT06929468 · CPN_PMU002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗