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NCT Number: NCT03914378

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

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.

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Key information

Conditions

Head and Neck Neoplasms Ear Diseases Hearing Disorders Hearing Loss Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location status: Recruiting

Location contact

Rachael Wilding

CONTACT

[email protected]

About this study

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:

Determine the impact of radiotherapy to the head and neck region on auditory function, including measures of hair cell and neural function
Determine the interaction between radiation and cisplatin chemotherapy on auditory function
Determine relations between different functional effects and radiation dose to substructures within the ear using advanced voxel-based data mining techniques
Determine the auditory substructure that is most associated with speech-in-noise deficits
Identify and validate a test which is most predictive of damage to that substructure, and could be the basis for future diagnosis
Validate the importance of the localised sensitive substructure in an independent cohort

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in Audiology test results for prospective cohort

Time frame: 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.
Audiology test results for retrospective cohort

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Plack, PhD

CONTACT

[email protected]

+44(161)275 3394

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Acronym: EARAD

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Apr 16, 2019
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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