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Study protocol: DexaDays-2, hydrocortisone for treatment of dexamethasone-induced neurobehavioral side effects in pediatric leukemia patients: a double-blind placebo controlled randomized intervention study with cross-over design by A. M. van Hulst; E. J. Verwaaijen; M. F. Fiocco; S. M. F. Pluijm; M. A. Grootenhuis; R. Pieters; E. L. T. van den Akker; M. M. van den Heuvel-Eibrink is a Medicine article available to read on EtoBox.
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## Abstract ## Background Dexamethasone, a highly effective drug in treating pediatric acute lymphoblastic leukemia (ALL), can induce serious neurobehavioral side effects. These side effects are experienced by patients and parents as detrimental with respect to health related quality of life (HRQoL). Based on previous studies, it has been suggested that neurobehavioral side effects are associated to cortisol depletion of the mineralocorticoid receptor in the brain. Our previously reported randomized controlled trial, the Dexadagen study (NTR3280), suggests that physiological hydrocortisone addition during dexamethasone treatment may overcome clinically relevant neurobehavioral problems in patients who experience these problems during dexamethasone treatment. With our current study, we aim to replicate these results in a targeted larger sample before further implementing this intervention into standard of care. ## Methods In a national center setting, pediatric ALL patients between 3 and 18 years are enrolled in an Identification study, which identifies patients with clinically relevant dexamethasone-induced neurobehavioral side effects using the Strengths and Difficulties Questionn
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- Author
- A. M. van Hulst; E. J. Verwaaijen; M. F. Fiocco; S. M. F. Pluijm; M. A. Grootenhuis; R. Pieters; E. L. T. van den Akker; M. M. van den Heuvel-Eibrink
- Publisher
- Springer Science and Business Media LLC
- Published
- 2021
- Language
- EN
- Field
- Medicine (Health Sciences)