Back to resultsSleep, Fatigue, and Dexamethosone in Children With Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethosone
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Drug Adverse Effect, Pediatric Cancer
Eligibility Criteria
Children and adolescents with Leukemia, both genders
Sites / Locations
- St. Jude Children Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Cycle
Arm Description
Outcomes
Primary Outcome Measures
Fatigue and sleep quality changes
Secondary Outcome Measures
Pharmacogenetics with dextamethasone use
Pharmacokinetics with dextamethasone use
Full Information
NCT ID
NCT00075101
First Posted
January 2, 2004
Last Updated
August 14, 2008
Sponsor
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00075101
Brief Title
Sleep, Fatigue, and Dexamethosone in Children With Leukemia
Official Title
Sleep, Fatigue, and Dexamethosone in Childhood Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Drug Adverse Effect, Pediatric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Cycle
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethosone
Other Intervention Name(s)
Mestinon
Intervention Description
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
Primary Outcome Measure Information:
Title
Fatigue and sleep quality changes
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Pharmacogenetics with dextamethasone use
Time Frame
5 days
Title
Pharmacokinetics with dextamethasone use
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children and adolescents with Leukemia, both genders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela S Hinds, PhD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sleep, Fatigue, and Dexamethosone in Children With Leukemia
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