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Radiotherapy and combined radiotherapy and chemotherapy are used to treat most tumours in the head and neck region. Unfortunately, these treatments often result in hearing loss and tinnitus that has a negative impact on quality of life. This study will use a battery of sensitive tests, including measures of hair cell and neural function, before and after treatment, to measure the effects of these treatments on auditory function. The results will be compared with the individual radiotherapy dose characteristics, using state-of-the-art data mining technology, to identify the auditory substructures that are most sensitive to radiation with respect to the effects on auditory function. The data will provide the basis for new dose constraints to limit radiation doses to any identified substructures and to minimise loss in hearing ability for patients undergoing treatment for head and neck cancer.
The overall aim is to provide the data that will define radiotherapy dose constraints for individual substructures of the auditory pathway such that a better balance can be made between hearing loss and tumour control during radiotherapy for head and neck cancer. In particular the study aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discovery Phase - Radiotherapy only | 25 patients undergoing radiotherapy only for head / neck cancer | ||
| Discovery Phase - Radiotherapy plus chemotherapy | 25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer | ||
| Validation Phase - Radiotherapy only | 25 patients undergoing radiotherapy only for head / neck cancer | ||
| Validation Phase - Radiotherapy plus chemotherapy | 25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer | ||
| Retrospective Cohort | 50 patients who previously received unilateral radiotherapy for head / neck cancer up to 5 years post-treatment | ||
| Normal Hearing Controls for Retrospective Cohort | 50 controls with normal hearing, age- and sex-matched to retrospective cohort | ||
| Hearing Impaired Controls for Retrospective Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Audiology test results for prospective cohort | For prospective patients undergoing radiotherapy to one side of the head, comparison of the test outcomes between the patient's two ears at baseline and 3 months, and relation to radiation dose characteristics. For prospective patients undergoing radiotherapy to both sides of the head, comparison of the test outcomes for both ears at baseline and at 3 months, and relation to radiation dose characteristics. | T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy. |
| Audiology test results for retrospective cohort | Comparison of test outcomes between treatment and non-treatment ears and relation to radiation does characteristics. Further comparison with hearing impaired and normal hearing control groups. | A single timepoint within 4 years post-treatment |
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For Prospective Patient Cohorts:
Inclusion Criteria:
Exclusion Criteria:
For Retrospective Patient Cohort:
Inclusion Criteria:
Exclusion Criteria:
For Retrospective Normal-Hearing Controls:
Exclusion Criteria:
For Retrospective Hearing-Impaired Controls:
Inclusion Criteria:
Exclusion Criteria:
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Patients with head and neck cancer and controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Plack, PhD | Contact | +44(161)275 3394 | Chris.Plack@manchester.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2022 | Dec 6, 2022 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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Tumour blocks.
One 10 ml (two teaspoons) blood sample at each time point:
50 controls with impaired hearing, age-, sex-, and audiogram-matched to retrospective cohort
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |