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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014