An observational study in Ototoxic Hearing Loss, Ototoxicity, Drug-Induced and Cisplatin-induced Hearing Loss, sponsored by Simon Jäger. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Simon Jäger · Observational
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.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's planned enrollment of 55 is below the median of 111 across 14 observational studies indexed under Ototoxicity.
Browse Ototoxicity studies →Simon Jäger is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with head and neck squamous cell carcinoma receiving treatment with cisplatin chemoradiotherapy or only radiotherapy at Klinikum Nuremberg in Nuremberg, Germany.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with head and neck squamous cell carcinoma receiving cisplatin chemotherapy and radiotherapy.
Adult patients with head and neck squamous cell carcinoma receiving only radiotherapy.
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Description of hearing loss through further testing
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.
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
Clinically relevant vestibulopathy: Increase in dizzyness symptoms \>18 points on the Dizziness Handicap Inventory (DHI) together with instrumentally measurable pathological changes in vestibular function: 1. 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. 2. Decrease in caloric excitability by more than 20%. 3. 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.
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
1. Dose-limiting nephrotoxicity, myelosuppression, gastrointestinal side effects (gingival deposits, stomatitis, diarrhoea, severe vomiting), fever, cisplatin-induced polyneuropathy \[documented as AESI\]. 2. Correlation between median cumulative cisplatin dose and adverse effects.
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
Completion of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 + HN43).
Time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Genetic variants related to cisplatin-induced ototoxicity
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).
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.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Jul 2025 → Jan 2026, on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Simon Jäger