The influence of radiotherapy and chemotherapy on hearing and tinnitus
Research type
Research Study
Full title
The Influence of Radiotherapy and Chemotherapy on Hearing and Tinnitus in Individuals with Head and Neck Cancer
IRAS ID
249390
Contact name
John Fitzgerald
Contact email
Sponsor organisation
Norfolk & Norwich University Hospital
Clinicaltrials.gov Identifier
249390, IRAS
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This study will investigate and monitor the influence of radiotherapy (RT) and chemotherapy (CHT) on hearing and tinnitus in adult patients with head and neck cancer. Further study is indicated due to the known ototoxic effects of RT and CHT; this research will aim to identify and quantify the extent of hearing loss and tinnitus in this patient group and to compare the proposed tests to assess their relative merits in detecting ototoxic damage.
We will perform a case history, otoscopy, tympanometry, conventional pure tone audiometry (PTA), extended high frequency pure tone audiometry (EHF PTA), distortion-product otoacoustic emissions (DPOAEs), Tinnitus and Hearing Survey (THS), and if needed the Tinnitus Functional Index (TFI). This study will be conducted in adults with head and neck cancer who have no previous record of RT or CHT treatment. Each participant will undergo a baseline measurement before treatment commences, a further measure on conclusion of treatment, and a final three month follow-up measurement post-treatment.
These investigations will be carried out between September 2018 and January 2020, with the last patients recruited in September 2019.
The results will provide quantitative information regarding the level of hearing loss and tinnitus in this patient group to address research gaps. Through identification of the best test to use a proposal for improved monitoring will be developed for a patient-centred monitoring protocol.
Any patient who experiences a significant hearing loss or tinnitus will be referred on for a hearing aid assessment and/or tinnitus therapy according to their needs.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0388
Date of REC Opinion
1 Oct 2018
REC opinion
Favourable Opinion