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Sleep, Fatigue, and Dexamethosone in Children With Leukemia
This study has been completed.
Study NCT00075101   Information provided by National Institute of Nursing Research (NINR)
First Received: January 2, 2004   Last Updated: August 14, 2008   History of Changes

January 2, 2004
August 14, 2008
September 2000
September 2006   (final data collection date for primary outcome measure)
Fatigue and sleep quality changes [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00075101 on ClinicalTrials.gov Archive Site
  • Pharmacogenetics with dextamethasone use [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics with dextamethasone use [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Pharmacogenetics with/without dextamethasone use [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics with/without dextamethasone use [ Time Frame: 10 days ] [ Designated as safety issue: No ]
 
Sleep, Fatigue, and Dexamethosone in Children With Leukemia
Sleep, Fatigue, and Dexamethosone in Childhood Cancer

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

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.

Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Leukemia
Drug: Dexamethosone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
134
September 2006
September 2006   (final data collection date for primary outcome measure)

Children and adolescents with Leukemia, both genders

Both
5 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075101
Pamela S. Hinds, St. Jude Children's Research Hospital
1-R01-NR007610-01
National Institute of Nursing Research (NINR)
 
Principal Investigator: Pamela S Hinds, PhD St. Jude Children's Research Hospital
National Institute of Nursing Research (NINR)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP