Sleep, Fatigue, and Dexamethosone in Children With Leukemia

Leukemia Clinical Trial

Official title:

Sleep, Fatigue, and Dexamethosone in Childhood Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075101
• Other study ID #: 1R01NR007610-01
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2004
• Last updated: August 14, 2008
• Start date: September 2000
• Est. completion date: September 2006

Study information

• Verified date: August 2008
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years
• Eligibility: Children and adolescents with Leukemia, both genders

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• Dexamethosone
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid

Locations

Country	Name	City	State
United States	St. Jude Children Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue and sleep quality changes		10 days	No
Secondary	Pharmacogenetics with dextamethasone use		5 days	No
Secondary	Pharmacokinetics with dextamethasone use		5 days	No