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| Tracking Information | |||||
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| First Received Date ICMJE | January 2, 2004 | ||||
| Last Updated Date | August 14, 2008 | ||||
| Start Date ICMJE | September 2000 | ||||
| Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Fatigue and sleep quality changes [ Time Frame: 10 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00075101 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Sleep, Fatigue, and Dexamethosone in Children With Leukemia | ||||
| Official Title ICMJE | Sleep, Fatigue, and Dexamethosone in Childhood Cancer | ||||
| Brief Summary | The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE | Drug: Dexamethosone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 134 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Children and adolescents with Leukemia, both genders |
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| Gender | Both | ||||
| Ages | 5 Years to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00075101 | ||||
| Responsible Party | Pamela S. Hinds, St. Jude Children's Research Hospital | ||||
| Study ID Numbers ICMJE | 1-R01-NR007610-01 | ||||
| Study Sponsor ICMJE | National Institute of Nursing Research (NINR) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Nursing Research (NINR) | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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