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

Sponsor
Simon Jäger
Study ID
NCT06929468
Status
Not Yet Recruiting

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Conditions

  • Cisplatin Ototoxicity
  • Cisplatin-induced Hearing Loss
  • Deafness
  • Dizzyness
  • Head and Neck Cancer
  • Hearing Loss
  • Inner Ear Hearing Loss
  • Ototoxic Hearing Loss
  • Ototoxicity, Drug-Induced
  • Squamous Cell Carcinoma of the Head and Neck
  • Vestibular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 16, 2025
Start date
Jul 31, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: Cisplatin chemoradiotherapy
    Adult patients with head and neck squamous cell carcinoma receiving cisplatin chemotherapy and radiotherapy.
  • Arm: Only radiotherapy
    Adult patients with head and neck squamous cell carcinoma receiving only radiotherapy.

Primary Outcome Measure

Tinnitus [ Time Frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment. ]

Central Contacts

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