NCT03914378

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Head and Neck Neoplasms
• Hearing Loss

Timeline

• Start date: 2019-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-04-16
• Last updated: 2024-05-08

Locations

1 site across 1 country: United Kingdom