160 Chapter 5 RESULTS During the inclusion period, 163 medium risk ALL patients were eligible, of which 105 gave informed consent and therefore were enrolled in our study (Figure 3). Median age of the included patients was 5.3 years (range 3.0-18.8 years) and 61% were boys. The mean week of maintenance treatment phase in which patients were enrolled was week 35 (±14 weeks) (Table 1). For each measurement there were missing values (Figure 3). The baseline characteristics of the patients who completed measurements and the patients with missing values were similar, except for the fat mass measurement: bioelectrical impedance analysis was obtained in less boys than girls: 19/64 boys (30%) refused this measurement, as opposed to 3/41 girls (7%). ALL-11 MR patients n=277 Eligible patients n=163 Informed Consent & Enrolled n=105 Fatigue n=92 (88%) Exclusion n=114 (41%) - Age (<3 or >18): n=17 - Language barrier: n=14 - No/less dexamethasone: n=17 - Participation in related study: n=12 - Mental retardation: n=9 - Hydrocortisone use: n=18 - Risperidone use: n=4 - Other: n=23 Refusal n=58 (35%) - Burden/effort: n=17 - No time: n=10 - Few side effects: n=10 - Child refuses: n=5 - Too many studies: n=3 - Not interested: n=5 - Other: n=5 - Unknown: n=3 ALL patients n=388 Exclusion n=111 (29%) - SR group: n=69 - HR group: n=25 - Not ALL-11: n=17 Sleep n=104 (99%) Hunger score n=89 (85%) Fat mass n=83 (79%) Leptin n=83 (79%) BMI n=89 (85%) Complete T1 and T2 data for Figure 3. Flow diagram After screening on in- and exclusion criteria, 163 eligible patients were asked to participate, of which 105 were enrolled in the study. Complete data for both timepoints (i.e. measurement before the start of a five-day dexamethasone course (T1) and after this course (T2) is depicted. Abbreviations: ALL: acute lymphoblastic leukemia, SR: standard risk, HR: high risk, MR: medium risk
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