Clinical trial · Observational
The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (7)
- label
- Discovery Phase - Radiotherapy only
- description
- 25 patients undergoing radiotherapy only for head / neck cancer
- label
- Discovery Phase - Radiotherapy plus chemotherapy
- description
- 25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
- label
- Validation Phase - Radiotherapy only
- description
- 25 patients undergoing radiotherapy only for head / neck cancer
- label
- Validation Phase - Radiotherapy plus chemotherapy
- description
- 25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
- label
- Retrospective Cohort
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available