Sleep, Fatigue, and Dexamethosone in Children With Leukemia - Full Text View

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 III

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Pyridostigmine Pyridostigmine bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Sleep, Fatigue, and Dexamethosone in Childhood Cancer

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
Study Cycle: Experimental	Drug: Dexamethosone 10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid

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

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

Keywords provided by National Institute of Nursing Research (NINR):

Drug Adverse Effect

Pediatric Cancer

Study placed in the following topic categories:

Leukemia

Fatigue

Pyridostigmine Bromide

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute of Nursing Research (NINR)
Information provided by:	National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:	NCT00075101