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Sleep, Fatigue, and Dexamethosone in Childhood Cancer


Phase 3
5 Years
21 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Sleep, Fatigue, and Dexamethosone in Childhood Cancer


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.

Inclusion Criteria


Children and adolescents with Leukemia, both genders

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Fatigue and sleep quality changes

Outcome Time Frame:

10 days

Safety Issue:

No

Principal Investigator

Pamela S Hinds, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

1-R01-NR007610-01

NCT ID:

NCT00075101

Start Date:

September 2000

Completion Date:

September 2006

Related Keywords:

  • Leukemia
  • Drug Adverse Effect
  • Pediatric Cancer
  • Leukemia

Name

Location
St. Jude Children Research Hospital Memphis, Tennessee  38105