None listed
Conditions
Interventions
During 2 identical periods of 5 days of dexamethasone treatment, in addition, patients will receive either a physiological dose of cortisol (intervention) or placebo.
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Age 3-16; 3. Histologically or cytologically confirmed acute lymphoblastic leukemia; 4. Inclusion in DCOG ALL10 or ALL11 protocol or ALL R3 protocol; 5. Able to comply with scheduled follow-up.
Exclusion criteria
Exclusion criteria: 1. Patient or parent refusal; 2. Anticipated compliance problems; 3. Underlying conditions which affect the absorption of oral medication; 4. Pregnant or lactating patients; 5. Current uncontrolled infection or any other complication which may interfere with dexamethasone treatment; 6. Language barrier; 7. Preexisting mental retardation syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameter is the parent-reported strength and difficulty questionnaire in Dutch (SDQ-Dut) 20 after 5 days of dexamethasone treatment with or without cortisol. In the general population mean SDQ score is 7,0 (1 SD= 6,0)20 . We expect the mean SDQ-Dut score of the children after 5 days of dexamethasone treatment to be around 15 in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are mood and behaviour questionnaires and (neuro-)cognitive tests and metabolic parameters (Data on body composition will be obtained. Height and weight will be measured. Waist-hip circumpherence and blood pressure will be measured. Fasting blood samples will be taken to measure lipid profiles (triglycerides, cholesterol, HDL, LDL), glucose and insulin levels). | — |
Contacts
Public ContactL.T. Warris
Erasmus MC, Dr Molewaterplein 60
Outcome results
None listed