Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
Primary Purpose
Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
laboratory biomarker analysis
metabolic assessment
questionnaire administration
assessment of therapy complications
fatigue assessment and management
quality-of-life assessment
Sponsored by
About this trial
This is an observational trial for Fatigue focused on measuring 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
Eligibility Criteria
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)
Sites / Locations
- Vanderbilt-Ingram Cancer Center - Cool Springs
- Vanderbilt-Ingram Cancer Center at Franklin
- Vanderbilt-Ingram Cancer Center
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT00801346
First Posted
December 2, 2008
Last Updated
April 20, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00801346
Brief Title
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
Official Title
The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
Study Type
Observational
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children
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
7. Study Design
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
metabolic assessment
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
Title
Family history as assessed by the Family History Questionnaire at baseline
Title
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
Title
Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
Title
Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
Title
IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J. Esbenshade, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
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