Ototoxicity monitoring in platinum based chemotherapy, version 1.
Research type
Research Study
Full title
Monitoring ototoxicity in patients undergoing treatment with platinum-based chemotherapy for sarcoma and testicular cancer using tablet based self-administered hearing tests
IRAS ID
271954
Contact name
Anne Schilder
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/10/09 , UCL Data Protection Registration
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Hearing loss is a serious and irreversible side-effect of platinum-based chemotherapy. Current management involves changing chemotherapy medications if hearing loss is detected. However, early detection is difficult as the only detection method involves regularly repeating in-hospital hearing tests. This is problematic as it adds to the onerous treatment schedule for these cancer patients. Additionally, the test is only positive after irreversible damage has already occurred.
The advent of Tablet Based Self-Administered (TBSA) hearing tests may in the future allow hearing health to be monitored more closely without increasing the burden of treatment. Additionally, there is now evidence from animal models that blood levels of an ear protein (prestin) may be used to detect ear damage earlier.
In this study we aim to investigate the feasibility of
a) Evaluating the use of TBSA Hearing tests to monitor hearing in patients more closely without increasing their burden of care
b) Measuring Prestin blood levels from scheduled blood tests to help predict those that are likely to develop hearing loss
We will recruit patients with Sarcomas and Germ-cell tumours through our routine UCLH-Barts cancer clinics. These patients are young, and mostly without risk factors for hearing loss, making interpretation of the findings less complicated.
We plan to recruit 40 patients over 6 months to participate in this study. Patients will undergo routine care with their usual medical teams. From their routine blood tests (taken five times throughout treatment), samples will also be processed for Prestin levels. Patients will also be asked to undertake short TBSA hearing tests and complete quality of life questionnaires during their five routinely scheduled hospital visits.
This study will demonstrate the feasibility of TBSA hearing tests and blood prestin levels in monitoring hearing health and inform future studies that can directly measure the benefit of these new approaches.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
19/LO/1988
Date of REC Opinion
27 Jan 2020
REC opinion
Favourable Opinion