Head and Neck NeoplasmsEARADNCT03914378
The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
An observational study of Head and Neck Neoplasms and Hearing Loss, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Neoplasms, Hearing Loss
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with head and neck cancer and controls
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 13Show fewer
- An MDT treatment decision of carboplatin based chemotherapy
- Unable to give informed consent
- For Retrospective Normal-Hearing Controls:
- 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:
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Rachael Wilding, Rachael.Wilding@christie.nhs.uk
About this study
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.
Read the 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:
- 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
- Conditions
- Head and Neck Neoplasms, Hearing Loss
- Keywords
- Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Audiology test results for prospective cohort
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.
Measured: T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy.
Audiology test results for retrospective cohort
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.
Measured: A single timepoint within 4 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 May 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Chris Plack, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914378
- Sponsor's protocol ID
- NHS001435
- Acronym
- EARAD
- Status last verified
- May 2024
- First submitted
- 9 Apr 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
- ClinicalTrials.gov ID
- NCT03914378
- Acronym / sponsor ID
- EARAD / NHS001435
- Conditions
- Head and Neck Neoplasms, Hearing Loss
- Keywords
- Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck cancer and controls
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Hearing Loss, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Plack, PhD (+44(161)275 3394, Chris.Plack@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Audiology test results for prospective cohort (time frame: T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.