Effects of Radiotherapy and Chemotherapy on Hearing in Head and Neck Cancer Patients

The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)

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
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Manchester (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Manchester)
• Trial ID: NCT03914378 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with head and neck cancer who are scheduled to receive radiotherapy with or without cisplatin chemotherapy.

Not a fit: Patients with pre-existing significant hearing loss or those receiving carboplatin-based chemotherapy may not benefit from this study.

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 performed: 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.

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

Where this trial is running

Manchester

• The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Chris Plack, PhD

Conditions Head and Neck Neoplasms; Hearing Loss; Radiotherapy