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Sleep, Fatigue, and Dexamethosone in Children With Leukemia

NCT ID: NCT00075101

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Leukemia

Keywords

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Drug Adverse Effect Pediatric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Cycle

Group Type EXPERIMENTAL

Dexamethosone

Intervention Type DRUG

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

Interventions

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Dexamethosone

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

Intervention Type DRUG

Other Intervention Names

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Mestinon

Eligibility Criteria

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Inclusion Criteria

Children and adolescents with Leukemia, both genders
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role lead

Responsible Party

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St. Jude Children's Research Hospital

Principal Investigators

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Pamela S Hinds, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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1R01NR007610-01

Identifier Type: NIH

Identifier Source: org_study_id

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