Ototoxic Hearing LossNCT06929468
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
An observational study of Ototoxic Hearing Loss and Ototoxicity, Drug-Induced, run by Simon Jäger at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ototoxic Hearing Loss, Ototoxicity, Drug-Induced, Cisplatin-induced Hearing Loss
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2026to Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck squamous cell carcinoma receiving treatment with cisplatin chemoradiotherapy or only radiotherapy at Klinikum Nuremberg in Nuremberg, Germany.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Nuremberg
Nuremberg, Bavaria, 90419
Prof. Dr. med. Simon Jäger, +49 911-398-2822, simon.jaeger@klinikum-nuernberg.de
Dr. Christine Le Roux, MBChB, christine.leroux@klinikum-nuernberg.de
About this study
Official title: Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
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
- Medical subject headings
- Ototoxicity, Head and Neck Neoplasms, Dizziness, Hearing Loss, Sensorineural, Vestibular Diseases, Squamous Cell Carcinoma of Head and Neck, Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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:
- 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.
Measured: 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
- 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.
Measured: 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).
Measured: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start20 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ototoxic Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Simon Jäger
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg
- Responsible party
- Sponsor-investigator, Simon Jäger, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929468
- Sponsor's protocol ID
- CPN_PMU002
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
- ClinicalTrials.gov ID
- NCT06929468
- Acronym / sponsor ID
- CPN_PMU002
- Conditions
- Ototoxic Hearing Loss, Ototoxicity, Drug-Induced, Cisplatin-induced Hearing Loss, Cisplatin Ototoxicity, Head and Neck Cancer, Dizzyness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Simon JägerUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck squamous cell carcinoma receiving treatment with cisplatin chemoradiotherapy or only radiotherapy at Klinikum Nuremberg in Nuremberg, Germany.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ototoxic Hearing Loss and Ototoxicity, Drug-Induced, run by Simon Jäger at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. Simon Jäger (+49 911-398-2822, simon.jaeger@klinikum-nuernberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus (time frame: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.