157 Leptin, hunger and fat 5 MATERIALS AND METHODS This study was conducted within the framework of the DexaDays-2 study: a national randomized clinical trial on dexamethasone-induced neurobehavioral problems in ALL patients at the Princess Máxima Center for Pediatric Oncology in the Netherlands, between 2019 and 2021. The design of this trial has been published previously.19,20 This study was approved by the Medical Ethical Committee of Rotterdam (NL62388.078.17) and was performed in compliance with the ethical standards of the Princess Máxima Center as well as with the Declaration of Helsinki. All parents and/or patients provided written informed consent to participate. Patients and treatment Patients between 3 and 18 years treated according to the Dutch Childhood Oncology Group (DCOG) ALL-11 protocol were eligible during maintenance treatment phase, after cessation of doxorubicin, as previously described.19 Dexamethasone (6 mg/m2/day) was administered for five consecutive days at the start of each three-weekly cycle. Data and venous blood samples were collected on the first day of a five-day dexamethasone course (T1) and on the morning after the same course (i.e. after five full days of dexamethasone treatment) (T2). Weight (kg) and height (cm) were measured at these timepoints and body mass index (BMI) was calculated. Parents completed several questionnaires at T1 and T2 (Figure 2). Measurements Hunger scores Parents were asked to indicate how hungry their child was at T1 and T2 by completing an 11-point Likert-type hunger scale (Eating Thermometer), where possible together with the child. Four different hunger scores were generated, with 0 indicating not hungry at all, and 10 indicating the hungriest possible. These four scores specified the average, most, least and fasting hunger score, with a recall over the past 24 hours. Such Likert-type hunger scales have not been validated, but have been used previously to assess feeling of hunger in adults and children.21,22 Fatigue and sleep Parents completed the validated Pediatric Quality of Life Inventory (PedsQL) – Multidimensional Fatigue Scale (MFS) to assess fatigue. Parental versions for four different age groups were used: 3-4, 5-7, 8-12 and 13-18 years. The total scores were compared to Dutch reference values to generate standardized deviation scores (SDS).23
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