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

Recruiting

• Conditions: Head and Neck Neoplasms; Hearing Loss

• Registration Number: NCT03914378
• Lead Sponsor: University of Manchester

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.

Detailed Description

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:

1. Determine the impact of radiotherapy to the head and neck region on auditory function, including measures of hair cell and neural function

2. Determine the interaction between radiation and cisplatin chemotherapy on auditory function

3. Determine relations between different functional effects and radiation dose to substructures within the ear using advanced voxel-based data mining techniques

4. Determine the auditory substructure that is most associated with speech-in-noise deficits

5. Identify and validate a test which is most predictive of damage to that substructure, and could be the basis for future diagnosis

6. Validate the importance of the localised sensitive substructure in an independent cohort

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-16
• Study Start: 2019-05-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Audiology test results for retrospective cohort	A single timepoint within 4 years post-treatment	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.
Change in Audiology test results for prospective cohort	T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy.	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.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom