Effects of Radiotherapy and Chemotherapy on Hearing in Head and Neck Cancer Patients
Official title: The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
Run by University of Manchester · NCT03914378 · Data updated 2026-11-12
This study is trying to see how treatments for head and neck cancer, like radiotherapy and chemotherapy, affect hearing in patients and which parts of the ear are most at risk of damage.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Manchester Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Manchester) |
| Status | Recruiting |
| Started | May 1, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 8, 2024 |
| Trial ID | NCT03914378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with head and neck cancer who are scheduled to receive radiotherapy with or without cisplatin chemotherapy.
✕Probably not a fit
Patients with pre-existing significant hearing loss or those receiving carboplatin-based chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates how radiotherapy and chemotherapy treatments for head and neck tumors affect auditory function, particularly focusing on hearing loss and tinnitus. It employs sensitive tests to assess hair cell and neural function before and after treatment, comparing results with individual radiotherapy dose characteristics. The goal is to identify which auditory substructures are most sensitive to radiation, ultimately aiming to establish new dose constraints to minimize hearing loss while effectively treating cancer. The study also seeks to validate predictive tests for damage to these sensitive substructures.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that reduce hearing loss in patients undergoing therapy for head and neck cancer.
How similar studies have gone: While the approach of assessing auditory function in relation to cancer treatments is established, this specific study's methodology and focus on substructures is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The Christie NHS Foundation Trust
Manchester, United Kingdom Recruiting
Study contacts
- Study coordinator: Chris Plack, PhD
- Email: Chris.Plack@manchester.ac.uk
- Phone: +44(161)275 3394
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.