Sleep, Fatigue, and Dexamethosone in Children With Leukemia

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Leukemia

Treatments: Drug: Dexamethosone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00075101

1R01NR007610-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Children and adolescents with Leukemia, both genders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 1 patient group

Study Cycle

Experimental group

Treatment:

Drug: Dexamethosone