Diepstraten Franciscus A, Meijer Annelot Jm, van Grotel Martine, Plasschaert Sabine LA, Hoetink Alexander E, Fiocco Marta, Janssens Geert O, Stokroos Robert J, van den Heuvel-Eibrink Marry M
Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Department of Otorhinolaryngology and Head & Neck Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
JMIR Res Protoc. 2022 Apr 7;11(4):e34297. doi: 10.2196/34297.
Some children with central nervous system (CNS) and solid tumors 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. Comedication, 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. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity.
The aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) 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 patients with solid and CNS tumors.
The SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the 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 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 the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the 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 NL8881; https://www.trialregister.nl/trial/8881.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34297.
一些患有中枢神经系统（CNS）肿瘤和实体瘤的儿童在治疗期间有发生耳毒性的风险。到目前为止，已经确定了几个可能导致耳毒性的危险因素，如铂类衍生物、颅脑照射和脑部手术。已知联合用药，如抗生素和利尿剂，会增强耳毒性，但它们对儿童癌症患者的独立影响尚未得到研究。关于听力损失筛查的建议缺失或在不同的治疗方案中差异很大。此外，对现有筛查指南的依从性并不总是最佳的。目前，耳毒性的患病率尚不清楚。
儿童癌症治疗期间耳毒性的患病率和决定因素研究（SOUND）的目的是确定听力测试的可行性，并确定在荷兰一个全国性的实体瘤和CNS肿瘤患者队列中，儿童癌症治疗期间耳毒性的患病率和决定因素。
SOUND研究是在荷兰国家儿童癌症中心进行的一项前瞻性队列研究。该研究旨在纳入所有0至19岁新诊断为CNS肿瘤或实体瘤的儿童。这些患者中的一部分将接受听力检查作为其标准治疗的一部分（第1层）。听力检查不是标准治疗的患者将被邀请纳入第2层。将在治疗开始前和治疗结束后3个月内进行年龄依赖性听力评估。除了听力损失，我们还将研究在癌症治疗后筛查患者耳鸣和眩晕患病率的可行性。本研究还将确定抗生素和利尿剂对耳毒性的独立影响。
本研究已获得乌得勒支医学研究伦理委员会批准（标识符20 - 417/M）。目前，我们正在进行这项研究的招募工作。
SOUND研究将提高对CNS肿瘤或实体瘤儿童治疗期间耳毒性存在的认识。它将深入了解耳毒性的患病率以及独立的临床和联合治疗相关决定因素。这对于识别未来的高危患者很重要。因此，该研究将为选择在目前正在筹备的儿童癌症治疗期间将从创新性耳保护干预试验中获益的患者提供依据。
荷兰试验注册库NL8881；https://www.trialregister.nl/trial/8881。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/34297。
