Leukemia
Conditions
Keywords
Drug Adverse Effect, Pediatric Cancer
Brief summary
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
Detailed description
Approximately 134 children and adolescents will be enrolled. All children and adolescents will wear a wrist actigraph for two consecutive 5-day study periods. Children and adolescents will have blood drawn 2 times on Day 1 when they are on dexamethosone. Their parents will complete a sleep diary and fatigue questionnaire by telephone on Days 2 and 5 of both study periods.
Interventions
DRUGDexamethosone
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
Sponsors
National Institute of Nursing Research (NINR)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Children and adolescents with Leukemia, both genders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue and sleep quality changes | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacogenetics with dextamethasone use | 5 days |
| Pharmacokinetics with dextamethasone use | 5 days |
Countries
United States
Outcome results
None listed