NCT00075101

Sleep, Fatigue, and Dexamethosone in Children With Leukemia

Sleep, Fatigue, and Dexamethosone in Childhood Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: National Institute of Nursing Research (NINR) · NIH
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Dexamethosone	10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid

Timeline

• Start date: 2000-09-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2004-01-05
• Last updated: 2008-08-18

Locations

1 site across 1 country: United States