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NCT Number: NCT06929468

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

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.

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Key information

Conditions

Ototoxic Hearing Loss Carcinoma Carcinoma, Squamous Cell Chemically-Induced Disorders Cisplatin Ototoxicity Cisplatin-induced Hearing Loss Deafness Dizziness Dizzyness Drug-Related Side Effects and Adverse Reactions Ear Diseases Head and Neck Cancer Head and Neck Neoplasms Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Inner Ear Hearing Loss Labyrinth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Ototoxicity Ototoxicity, Drug-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Sensation Disorders Signs and Symptoms Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Head and Neck Vestibular Disease Vestibular Diseases Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Nuremberg

Nuremberg, Bavaria, 90419, Germany

Location contact

Dr. Chantal Degen, MSc

PRINCIPAL_INVESTIGATOR

Dr. Christine Le Roux, MBChB

CONTACT

[email protected]

Prof. Dr. med. Simon Jäger

CONTACT

[email protected]

+49 911-398-2822

Prof. Dr. med. Simon Jäger

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tinnitus

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

    Incidence and severity of new or exacerbated tinnitus during treatment with cisplatin chemotherapy measured as impairment according to the Tinnitus Handicap Inventory (THI) score:

    0-16 = no impairment. 18-36 = mild impairment. 38-56 = moderate impairment. 58-76 = severe impairment. 78-100 = catastrophic impairment.

  2. Hearing loss

    Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.

    Incidence of significant hearing loss during treatment with cisplatin chemotherapy described according to CTCAE (Common Terminology Criteria for Adverse Events) in 1-8 kHz audiogram:

    Grade 1 = threshold shift 15-25 dB in 2 contiguous test frequencies in at least one ear.

    Grade 2 = threshold shift >25 dB in 2 contiguous test frequencies in at least one ear.

    Grade 3 = threshold shift of >25 dB averaged at 3 contiguous test frequencies in at least one ear.

    Grade 4 = decrease in hearing to profound bilateral loss, absolute threshold >80 dB at 2 kHz and above.

  3. Vestibular dysfunction

    Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.

    Incidence of dizziness or balance disturbances during treatment with cisplatin chemotherapy as determined through the Dizziness Handicap Inventory (DHI); changes of >18 indicates a clinical relevant worsening in condition:

    0-29 = no to mild impairment. 30-60 = moderate impairment. >60 = severe impairment.

Secondary outcomes

  1. 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 hearing loss requiring treatment according to the Freiburger Einsilber hearing test (≤80% of speech recognition is an indication for hearing aid): proportion of patients with loss of distortion product otoacoustic emissions (DPOAEs) and new hearing loss in high frequency audiometry at 8 - 16 kHz.

    Investigating the usefulness of high frequency audiometry when compared to DPOAEs for early recognition of ototoxicity.

  2. 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.

    Clinically relevant vestibulopathy: Increase in dizzyness symptoms >18 points on the Dizziness Handicap Inventory (DHI) together with instrumentally measurable pathological changes in vestibular function:

    • Decrease in VOR-Gain in the video head impulse test (vHIT) (from ca. 1 by 0,2 to 0,8) or new overt or covert saccades.
    • Decrease in caloric excitability by more than 20%.
    • Increase in non-elicitable vestibular evoked myogenic potentials (VEMPs) during therapy or a new amplitude asymmetry of more than 50%; prolongation of VEMP latency by more than 0.2 ms.

  3. 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.

    • Dose-limiting nephrotoxicity, myelosuppression, gastrointestinal side effects (gingival deposits, stomatitis, diarrhoea, severe vomiting), fever, cisplatin-induced polyneuropathy [documented as AESI].
    • Correlation between median cumulative cisplatin dose and adverse effects.

  4. 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.

    Completion of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 + HN43).

Other outcomes

  1. Genetic variants related to cisplatin-induced ototoxicity

    Time frame: 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.

    Prevalence of genetic variants that are predicitve and/or protective of inner ear damage during treatment with cisplatin chemotherapy (optional - patients can choose to only take part in the main study and not in the genetic analysis).

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Chantal Degen, MSc

CONTACT

[email protected]

+49 911-398-112583

Prof. Dr. med. Simon Jäger

CONTACT

[email protected]

+49 911-398-2822

Sponsors and collaborators

Lead sponsor

Simon Jäger

Other

Collaborators

  • Klinikum Nürnberg

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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