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| Name | Class |
|---|---|
| Klinikum Nürnberg | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with head and neck squamous cell carcinoma receiving treatment with cisplatin chemoradiotherapy or only radiotherapy at Klinikum Nuremberg in Nuremberg, Germany.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nuremberg | Nuremberg | Bavaria | 90419 | Germany |
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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.
| 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:
| 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 | Completion of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 + HN43). | From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion. |
| ID | Term |
|---|---|
| D000081015 | Ototoxicity |
| D006258 | Head and Neck Neoplasms |
| D004244 | Dizziness |
| D006319 | Hearing Loss, Sensorineural |
| D015837 | Vestibular Diseases |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D003638 | Deafness |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006311 | Hearing Disorders |
| D009422 | Nervous System Diseases |
| D007759 | Labyrinth Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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