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Sleep, Fatigue, and Dexamethosone in Children With Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00075101
First received: January 2, 2004
Last updated: August 14, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Leukemia
 Drug: Dexamethosone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep, Fatigue, and Dexamethosone in Childhood Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Fatigue and sleep quality changes [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 134
Study Start Date: September 2000
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Cycle Drug: Dexamethosone
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
Other Name: Mestinon

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.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Children and adolescents with Leukemia, both genders

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pamela S. Hinds, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00075101     History of Changes
Other Study ID Numbers: 1-R01-NR007610-01
Study First Received: January 2, 2004
Last Updated: August 14, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013