FatigueNCT00801346
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
An observational study of Fatigue and Leukemia, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease. PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children
- What is being tested?
- laboratory biomarker analysis, metabolic assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Apr 2016
- Phase
- Observational
- 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 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
Part 1
- Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL)
- In first remission
- In first 3 months of maintenance therapy
- No T-cell ALL, very high-risk ALL, or infant ALL (< 1 year old at diagnosis)
Part 2
- Diagnosis of precursor B-cell or T-cell ALL
- In first remission
- Must have been diagnosed and treated (at least to the maintenance phase) at the Division of Pediatric Oncology at the Vanderbilt-Ingram Cancer Center within the past 7 years
- No very high-risk ALL or infant ALL (< 1 year old at diagnosis)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior or concurrent cranial radiotherapy (Part 1)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.
Read the detailed description
OBJECTIVES:
Primary
- To determine the incidence and prevalence of the components of metabolic syndrome (e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with acute lymphoblastic leukemia in remission.
- To determine the trajectory of the onset of these components over a 1-year period in patients undergoing maintenance therapy.
Secondary
- To identify potential associations between components of metabolic syndrome and fatigue, health-related quality of life, family history, nutrition, and physical activity.
- To identify potential biomarkers that are associated with clinical features of metabolic syndrome.
- To evaluate whether patients will show a decrease in IGF-1 levels.
OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.
- Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist circumference, and blood pressure) at baseline (during maintenance course 1) and at 12 months (during maintenance course 5). Patients also undergo blood sample collection at baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile, fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their parents complete a family history questionnaire at baseline and questionnaires to assess physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6 and 12 months.
- Part 2: Patients or their parents complete a family history questionnaire at baseline.
- Being tested
- laboratory biomarker analysis, metabolic assessment, questionnaire administration, assessment of therapy complications, fatigue assessment and management
- Keywords
- fatigue, long-term effects secondary to cancer therapy in children, childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia
- Medical subject headings
- Fatigue, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
metabolic assessmentOther
questionnaire administrationOther
assessment of therapy complicationsProcedure or surgery
fatigue assessment and managementProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose)
Secondary outcomes (6)
Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
Family history as assessed by the Family History Questionnaire at baseline
Health-related quality of life as assessed by the Pediatric Quality of Life Inventory and the Pediatric Quality of Life Cancer Module at baseline and at 6 and 12 months
Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Adam Esbenshade, Vanderbilt University Medical Center
- Investigators
- Adam J. Esbenshade, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801346
- Sponsor's protocol ID
- CDR0000624471
- Other IDs
- P30CA068485, VU-VICC-PED-0872, IRB# 081043
- Status last verified
- Apr 2017
- First submitted
- 2 Dec 2008
- Last updated
- 21 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
- ClinicalTrials.gov ID
- NCT00801346
- Acronym / sponsor ID
- CDR0000624471
- Keywords
- fatigue, long-term effects secondary to cancer therapy in children, childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Dec 2008 (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.
RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.
Detailed description
OBJECTIVES:
Primary
- To determine the incidence and prevalence of the components of metabolic syndrome (e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with acute lymphoblastic leukemia in remission.
- To determine the trajectory of the onset of these components over a 1-year period in patients undergoing maintenance therapy.
Secondary
- To identify potential associations between components of metabolic syndrome and fatigue, health-related quality of life, family history, nutrition, and physical activity.
- To identify potential biomarkers that are associated with clinical features of metabolic syndrome.
- To evaluate whether patients will show a decrease in IGF-1 levels.
OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.
- Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist circumference, and blood pressure) at baseline (during maintenance course 1) and at 12 months (during maintenance course 5). Patients also undergo blood sample collection at baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile, fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their parents complete a family history questionnaire at baseline and questionnaires to assess physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6 and 12 months.
- Part 2: Patients or their parents complete a family history questionnaire at baseline.
Study design
Who may qualify
- Ages
- 1 year to 20 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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| metabolic assessment | Other | – |
| questionnaire administration | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| fatigue assessment and management | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose)
6 secondary outcomes
Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
Family history as assessed by the Family History Questionnaire at baseline
Health-related quality of life as assessed by the Pediatric Quality of Life Inventory and the Pediatric Quality of Life Cancer Module at baseline and at 6 and 12 months
Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months
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 21 Apr 2017.
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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.
Adam J. Esbenshade, MD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Leukemia, run by Vanderbilt University Medical Center at 3 sites 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose). 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 21 Apr 2017.