NCT00075101

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started Sep 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

Enrollment Period

6 years

First QC Date

January 2, 2004

Last Update Submit

August 14, 2008

Conditions

Leukemia

Keywords

Drug Adverse EffectPediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • Fatigue and sleep quality changes

    10 days

Secondary Outcomes (2)

  • Pharmacogenetics with dextamethasone use

    5 days

  • Pharmacokinetics with dextamethasone use

    5 days

Study Arms (1)

Study Cycle

EXPERIMENTAL
Drug: Dexamethosone

Interventions

DexamethosoneDRUG

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

Also known as: Mestinon
Study Cycle

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Children and adolescents with Leukemia, both genders

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

LeukemiaDrug-Related Side Effects and Adverse ReactionsNeoplasms

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pamela S Hinds, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

January 2, 2004

First Posted

January 5, 2004

Study Start

September 1, 2000

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

August 18, 2008

Record last verified: 2008-08

Locations

US(1)