Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT03914378

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

Led by University of Manchester · Updated on 2024-05-08

100

Participants Needed

1

Research Sites

395 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with head and neck cancer
  • An MDT treatment decision of radiotherapy with or without cisplatin based chemotherapy
  • Previously diagnosed and treated for head and neck cancer (retrospective cohort)
  • Radiotherapy treatment to one side of the head (retrospective cohort)
  • Within 5 years post-treatment (retrospective cohort)
  • Hearing loss greater than 20 dB HL (average from 0.25 to 4 kHz) for hearing-impaired controls
Not Eligible

You will not qualify if you...

  • Hearing loss greater than 25 dB HL (average from 0.25 to 4 kHz) prior to the study
  • Existing hearing loss requiring hearing aid
  • An MDT treatment decision of carboplatin based chemotherapy
  • Involved in another research project with known ototoxic treatment
  • Unable to give informed consent
  • Hearing loss greater than 20 dB HL at any octave frequency from 0.25 to 4 kHz for normal-hearing controls

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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Research Team

C

Chris Plack, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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