101 Study protocol 3 METHODS General study design The DexaDays-2 study is a Dutch national study and is coordinated from the Princess Máxima Center for pediatric oncology. The study consists of two parts: an Identification study (T1-T2) and a Randomized Controlled Trial (RCT) (T3-T11). Figure 1 gives a schematic overview of the complete study. Tables 1 and 2 depict the content of all measurements in the Identification study and RCT, respectively. In- and exclusion criteria Every Dutch ALL patient is screened on in- and exclusion criteria. After permission of their pediatric oncologist, eligible patients are approached by the study team. Patients are eligible if they fulfill the following criteria: age 3–18, confirmed diagnosis of acute lymphoblastic leukemia (ALL), inclusion in DCOG ALL MRG protocol and able to comply with scheduled follow-up. Only patients between 3 and 18 years can participate because our questionnaires are validated for these ages. Exclusion criteria are: patient or parent refusal, anticipated compliance problems, underlying conditions which affect the absorption of oral medication, pregnant or lactating patients, current uncontrolled infection or any other complications which may interfere with dexamethasone treatment, language barrier, preexisting mental retardation, current hydrocortisone use or risperidone use. In addition, to be eligible for the RCT, a patient has to show a rise of five or more points on the SDQ Total Difficulties scale after five days of dexamethasone treatment. Randomized Controlled Trial The main study is a prospective double-blind placebo-controlled randomized trial (RCT) with a cross-over design. The primary aim of the RCT is to replicate the finding that addition of physiological doses of hydrocortisone to standard dexamethasone treatment reduces neurobehavioral side effects in pediatric ALL patients who suffer from clinically relevant dexamethasone-induced neurobehavioral problems. Neurobehavioral problems are measured with the parent-reported Strengths and Difficulties Questionnaire in Dutch (SDQ)27 at every time point (T3-T11) (Figure 1 and Table 2).
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