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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Diagnosed with head and neck cancer

• An MDT treatment decision of radiotherapy +/- cisplatin based chemotherapy

• 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

• Hearing loss greater than 20 dB HL (average from 0.25 to 4 kHz)

Locations
Other Locations
United Kingdom
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Chris Plack, PhD
Chris.Plack@manchester.ac.uk
+44(161)275 3394
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Discovery Phase - Radiotherapy only
25 patients undergoing radiotherapy only for head / neck cancer
Discovery Phase - Radiotherapy plus chemotherapy
25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
Validation Phase - Radiotherapy only
25 patients undergoing radiotherapy only for head / neck cancer
Validation Phase - Radiotherapy plus chemotherapy
25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
Retrospective Cohort
50 patients who previously received unilateral radiotherapy for head / neck cancer up to 5 years post-treatment
Normal Hearing Controls for Retrospective Cohort
50 controls with normal hearing, age- and sex-matched to retrospective cohort
Hearing Impaired Controls for Retrospective Cohort
50 controls with impaired hearing, age-, sex-, and audiogram-matched to retrospective cohort
Related Therapeutic Areas
Sponsors
Leads: University of Manchester

This content was sourced from clinicaltrials.gov