NCT03914378 The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
| NCT ID | NCT03914378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Head and Neck Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2019-05-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
For Prospective Patient Cohorts: Inclusion Criteria: * Diagnosed with head and neck cancer * An MDT treatment decision of radiotherapy +/- cisplatin based chemotherapy Exclusion Criteria: * Hearing loss greater than 25 dB HL (average from 0.25 to 4 kHz) prior to the study * Existing hearing loss (self-reported- need for hearing aid) * An MDT treatment decision of carboplatin based chemotherapy * Involved in another research project where the treatment is known to be ototoxic * Unable to give informed consent For Retrospective Patient Cohort: Inclusion Criteria: * Previously diagnosed and treated for head and neck cancer * Radiotherapy treatment to one side of the head * Within 5 years post-treatment * An MDT treatment decision of radiotherapy +/- cisplatin based chemotherapy Exclusion Criteria: * An MDT treatment decision of carboplatin based chemotherapy * Unable to give informed consent For Retrospective Normal-Hearing Controls: Exclusion Criteria: * Hearing loss greater than 20 dB HL (at any octave frequency from 0.25 to 4 kHz) * Unable to give informed consent For Retrospective Hearing-Impaired Controls: Inclusion Criteria: * Hearing loss greater than 20 dB HL (average from 0.25 to 4 kHz) Exclusion Criteria: * Unable to give informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03914378 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03914378 currently recruiting?
Yes, NCT03914378 is actively recruiting participants. Contact the research team at Chris.Plack@manchester.ac.uk for enrollment information.
Where is the NCT03914378 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT03914378 clinical trial?
NCT03914378 is sponsored by University of Manchester. The trial plans to enroll 100 participants.