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Sleep, Fatigue, and Dexamethosone in Children With Leukemia

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ClinicalTrials.gov Identifier: NCT00075101
Recruitment Status : Completed
First Posted : January 5, 2004
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Leukemia Drug: Dexamethosone Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep, Fatigue, and Dexamethosone in Childhood Cancer
Study Start Date : September 2000
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Leukemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Study Cycle Drug: Dexamethosone
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
Other Name: Mestinon


Outcome Measures

Primary Outcome Measures :
  1. Fatigue and sleep quality changes [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Pharmacogenetics with dextamethasone use [ Time Frame: 5 days ]
  2. Pharmacokinetics with dextamethasone use [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Children and adolescents with Leukemia, both genders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075101


Locations
United States, Tennessee
St. Jude Children Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Pamela S Hinds, PhD St. Jude Children's Research Hospital
More Information

Responsible Party: Pamela S. Hinds, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00075101     History of Changes
Other Study ID Numbers: 1R01NR007610-01 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2004    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

Keywords provided by National Institute of Nursing Research (NINR):
Drug Adverse Effect
Pediatric Cancer

Additional relevant MeSH terms:
Leukemia
Fatigue
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms