A prospective study on prevalence and determinants of ototoxicity during treatment of childhood cancer (SOUND study) (Preprint)

Abstract

Some children with central nervous system (CNS) and solid tumours are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation and brain surgery. Co-medication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing, or vary highly across treatment protocols. Also, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity.

The aim of the SOUND study is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of solid- and CNS tumour patients.

The SOUND study is a prospective cohort study in the national childhood cancer centre in The Netherlands. The study aims to include all children aged 0 until 19 years with a newly diagnosed CNS or solid tumour. Part of these patients will get audiological examination as part of standard of care (stratum 1). Patients in which audiological examination is not standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before start of treatment and within three months after end of treatment. Apart from hearing loss we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity.

This study was approved by the Medical Research Ethics Committee (METC) Utrecht (Identifier: 20-417/M). Currently, we are in the process of recruitment for this study.

The SOUND study will raise awareness about the presence of ototoxicity during treatment of children with CNS or solid tumours. It will give insight in the prevalence and independent clinical and (co-)treatment-related determinants of ototoxicity. This is important for identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment, that are currently being prepared.

Netherlands Trial Register: Trial NL8881