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

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ClinicalTrials.gov Identifier: NCT03914378
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Chris Plack, 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.

Condition or disease
Head and Neck Neoplasms Hearing Loss

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Audiology test results [ Time Frame: 3 months following Radiotherapy ]
    Comparison of the test outcomes between the patient's two ears at baseline and 3 months, and relation to radiation dose characteristics.


Biospecimen Retention:   Samples With DNA

Tumour blocks.

One 10 ml (two teaspoons) blood sample at each time point:

  1. Baseline (2 repeats)- one repeat at the planning scan and one repeat on day 1 of RT (prior to RT)
  2. Further time points: one per week throughout treatment (5 time points)
  3. Final visit: one 10ml EDTA blood to be taken at 3 months.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with head and neck cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914378


Contacts
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Contact: Chris Plack, PhD +44(161)275 3394 Chris.Plack@manchester.ac.uk

Locations
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United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Rachael Wilding       Rachael.Wilding@christie.nhs.uk   
Sponsors and Collaborators
University of Manchester
  Study Documents (Full-Text)

Documents provided by Professor Chris Plack, University of Manchester:
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Responsible Party: Professor Chris Plack, Ellis Llwyd Jones Professor of Audiology, University of Manchester
ClinicalTrials.gov Identifier: NCT03914378    
Other Study ID Numbers: NHS001435
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Chris Plack, University of Manchester:
Radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Neoplasms by Site
Neoplasms