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Sleep, Fatigue, and Dexamethosone in Children With Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00075101
First Posted: January 5, 2004
Last Update Posted: August 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Nursing Research (NINR)
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacogenetics with dextamethasone use [ Time Frame: 5 days ]
  • Pharmacokinetics with dextamethasone use [ Time Frame: 5 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: January 2, 2004
First Posted: January 5, 2004
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