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Completed

NCT Number: NCT00075101

Sleep, Fatigue, and Dexamethosone in Children With Leukemia

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

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Key information

Conditions

Leukemia Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Jude Children Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Children and adolescents with Leukemia, both genders

Treatment and study plan

Dexamethosone

Drug

10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid

Other names: Mestinon

Primary outcomes

  1. Fatigue and sleep quality changes

    Time frame: 10 days

Secondary outcomes

  1. Pharmacogenetics with dextamethasone use

    Time frame: 5 days

  2. Pharmacokinetics with dextamethasone use

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

Sleep, Fatigue, and Dexamethosone in Childhood Cancer

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Jan 5, 2004
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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