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Sleep, Fatigue, and Dexamethosone in Children with Leukemia

This study is currently recruiting patients.

Sponsored by: National Institute of Nursing Research (NINR)
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 Treatment or Intervention Phase
Leukemia
 Drug: Dexamethosone
Phase III

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

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: 

Expected Total Enrollment:  134

Study start: September 2000;  Study completion: June 2004

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   -   21 Years,  Genders Eligible for Study:  Both

Criteria

Children and adolescents, both genders

Location and Contact Information


Tennessee
      St. Jude Children Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Pamela S Hinds, PhD  901-495-2145    PAM.HINDS@STJUDE.ORG 

More Information

Study ID Numbers:  1-R01-NR007610-01
Record last reviewed:  January 2004
Record first received:  January 2, 2004
ClinicalTrials.gov Identifier:  NCT00075101
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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