NCT00075101

CompletedPhase 3

Sleep, Fatigue, and Dexamethosone in Children With Leukemia

National Institute of Nursing Research (NINR)Source

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Other study identifiers

Sponsor study identifier

1R01NR007610-01

NIH

Study Type

interventional

Estimated enrollment

134

Locations

1 country

Sites

1

Timeline

Study Start

September 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

Study Completion

September 2006

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 134 participants
Study completion date: September 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2000
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 2, 2004
Actual (reported)
First Posted
January 5, 2004
Actual (reported)
Primary Completion
September 2006
Actual (reported)
Study Completion
September 2006
Actual (reported)

Last Updated: August 18, 2008
Status Verified: August 2008
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

National Institute of Nursing Research (NINR)
NIHlead

Study Sites (1)

St. Jude Children Research Hospital

Memphis, Tennessee, 38105, United States

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 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

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Phase 3Completed

NCT00019409

Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia

Phase 3Withdrawn

NCT00005585

Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

Phase 3Completed

NCT00005596

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3Completed

NCT00003764

Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

Phase 3Completed

Study Completion

September 2006

Actual (reported)

Last Updated

August 18, 2008

Record last verified: 2008-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00075101
Data provider: ClinicalTrials.gov
Source updated: 2008-08-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:28 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Study Cycle

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations