Acute lymphoblastic leukemia, behavior, sleep, mood, quality of life, frailty
Conditions
Interventions
The intervention consists of 4 identical dexamethasone courses (duration 5 days), during which patients will receive addition of either hydrocortisone (2 consecutive courses) or placebo (2 consecutive
Sponsors
Princes Maxima Centre for pediatric oncology
Eligibility
Inclusion criteria
Inclusion criteria: - Written informed consent - Age 3-18 - Confirmed diagnosis of acute lymphoblastic leukemia (ALL) - Inclusion in DCOG ALL medium risk group protocol - Able to comply with scheduled follow-up
Exclusion criteria
Exclusion criteria: - 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 - Pre-existing mental retardation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurobehavioral problems after 5 days of dexamethasone treatment with or without hydrocortisone addition. These neurobehavioral problems will be measured with the parent-reported SDQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Dexamethasone related sleeping difficulties after 5 days of dexamethasone treatment with or without hydrocortisone, measured by the Sleep Disturbance Scale for Children (SDSC) and actigraphy. - Quality of life after 5 days of dexamethasone treatment with or without hydrocortisone addition, measured with the Pediatric Quality of Life questionnaire (PedsQL). - The prevalence of frailty and the influence of 5 days of dexamethasone on the different frailty parameters, measured through actigraphy, bio-impedance, ultrasonography, Timed ‘Up and Go’ test, activity questionnaire and handgrip strength. Furthermore we will study possible factors influencing the inter-patient variability in developing neurobehavioral side effects: - Dexamethasone kinetics (i.e. trough and peak levels) and the effect on the development of dexamethasone induced clinically relevant neurobehavioral and sleeping problems. - Carrier status of candidate single nucleotide polymorphisms (SNPs) and the influence on the development of dexamethasone induced clinically relevant neurobehavioral problems. - Psychosocial and environmental factors (measured through several questionnaires) that potentially determine the development of dexamethasone induced clinically relevant neurobehavioral problems. - The influence of hydrocortisone addition to dexamethasone treatment on the different frailty parameters. | — |
Contacts
Public ContactA.M. van Hulst
Prinses Maxima Centrum
Outcome results
None listed