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

NCT06929468 | Not Yet Recruiting

• 1 other identifier: CPN_PMU002
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Tinnitus

  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.

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

• Hearing loss

  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.

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

• Vestibular dysfunction

  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.

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

Secondary Outcomes (4)

• Description of hearing loss through further testing

  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

  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

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

• Assessment of tumour-related quality of life

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

Other Outcomes (1)

• Genetic variants related to cisplatin-induced ototoxicity

  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.

Study Arms (2)

Cisplatin chemoradiotherapy

Adult patients with head and neck squamous cell carcinoma receiving cisplatin chemotherapy and radiotherapy.

Only radiotherapy

Adult patients with head and neck squamous cell carcinoma receiving only radiotherapy.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Simon Jäger: lead
• Klinikum Nürnberg: collaborator

Study Sites (1)

Klinikum Nuremberg

Nuremberg, Bavaria, 90419, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients can take part in an optional genetic analysis where blood samples will be taken to assess for genes that predispose to developing inner ear damage during chemotherapy with cisplatin.

MeSH Terms

Conditions

Ototoxicity; Head and Neck Neoplasms; Dizziness; Hearing Loss, Sensorineural; Vestibular Diseases; Squamous Cell Carcinoma of Head and Neck; Deafness; Hearing Loss

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Hearing Disorders; Nervous System Diseases; Labyrinth Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Prof. Dr. med. Simon Jäger

CONTACT

+49 911-398-2822; simon.jaeger@klinikum-nuernberg.de

Dr. Chantal Degen, MSc

CONTACT

+49 911-398-112583; chantal.degen@klinikum-nuernberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head: Institute of Clinical Pharmacology

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)