LeukemiaPhase 3NCT00075101
Sleep, Fatigue, and Dexamethosone in Children With Leukemia
A Phase 3 study testing Dexamethosone in people with Leukemia, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Dexamethosone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Children and adolescents with Leukemia, both genders
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Sleep, Fatigue, and Dexamethosone in Childhood Cancer
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
Read the detailed 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.
- Conditions
- Leukemia
- Being tested
- Dexamethosone
- Keywords
- Drug Adverse Effect, Pediatric Cancer
- Medical subject headings
- Leukemia, Drug-Related Side Effects and Adverse Reactions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethosoneDrug
Also called Mestinon
10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
| Study group | Role | What they receive |
|---|---|---|
| Study Cycle | Experimental | Not described Receives: Drug: Dexamethosone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue and sleep quality changes
Measured: 10 days
Secondary outcomes (2)
Pharmacogenetics with dextamethasone use
Measured: 5 days
Pharmacokinetics with dextamethasone use
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2004 (estimated)
- Study startSep 2000
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Pamela S Hinds, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075101
- Sponsor's protocol ID
- 1R01NR007610-01
- Status last verified
- Aug 2008
- First submitted
- 2 Jan 2004
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Fatigue, and Dexamethosone in Childhood Cancer
- ClinicalTrials.gov ID
- NCT00075101
- Acronym / sponsor ID
- 1R01NR007610-01
- Conditions
- Leukemia
- Keywords
- Drug Adverse Effect, Pediatric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 5 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cycle | Experimental | Drug: Dexamethosone |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethosoneAlso: Mestinon10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid | Drug | Study Cycle |
Primary outcome
Fatigue and sleep quality changes
Time frame: 10 days
2 secondary outcomes
Pharmacogenetics with dextamethasone use
Time frame: 5 days
Pharmacokinetics with dextamethasone use
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela S Hinds, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethosone in people with Leukemia, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue and sleep quality changes (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.