Ototoxicity monitoring in aminoglycoside/cisplatin exposed patients-v1
Research type
Research Study
Full title
Investigating auditory monitoring for ototoxicity in aminoglycoside or chemotherapy exposed patients-v1
IRAS ID
118453
Contact name
Ghada Al-Malky
Contact email
Sponsor organisation
University College london (UCL)
Research summary
Ototoxicity is damage to hearing and balance function due to intake of drugs. They lead to permanent high frequency sensorineural hearing loss which, when affecting children leads to impaired speech and language development, social and behavioral problems and in turn affects patients’ quality of life. Two confirmed ototoxic groups of medications include aminoglycoside (AG) antibiotics and chemotherapeutic drugs such as cisplatin. Use of these drugs is limited to patients with life-threatening conditions as cystic fibrosis (CF) patients needing AGs for severe chest infections and cancer patients needing chemotherapy.
The incidence of hearing impairment with AG in CF patients was reported to range from 0-51% with low incidence reported in children (0-6%). Our previous research (Al-Malky et al., 2011) has shown that the incidence in CF children was 21% and that many children were exposed to repeated courses of AGs every 2-3 months from a very young age leading to cumulative exposure of 30-40 courses by the age of 16 years. Cisplatin has a reported incidence of 60-100% in patients especially when in extreme ages (children or elderly).
Ototoxicity is one of the preventable causes of hearing loss as stoppage or modification of exposure to these drugs can prevent further progression of damage to the inner ear. Therefore, auditory monitoring for early detection of ototoxicity is vital in allowing managing physicians to make informed decisions regarding their treatment regimes and preventing ototoxicity. The ASHA (American Speech and Hearing Association) has made recommendation for repeated regular baseline and post-treatment auditory monitoring in audiology departments. This is very useful but may prove difficult as it is time consuming and inconvenient, especially in very ill patients, and needs many resources (sound-proof rooms, qualified audiologists, expensive equipment). In this research we are aiming to assess the validity of using a set of quick and easy screening auditory tests that can be performed on the ward or outpatient clinic for early detection of ototoxicity. Results will be measured against comprehensive audiometric results as ‘gold standard’. If these are shown to have a high level of sensitivity and specificity then a screening monitoring protocol may be utilized where nurses can perform these tests with minimal audiology training. We are also aiming to conduct surveys to assess the current provision of ototoxicity monitoring services in CF, Cancer and Audiology centres in the UK as a provisional step on rolling out this proposal to other centres.REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/0624
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion