Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).

Conditions
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Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: metabolic assessment
* Other: questionnaire administration
* Procedure: assessment of therapy complications
* Procedure: fatigue assessment and management
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: metabolic assessment|nan|
|Other: questionnaire administration|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: fatigue assessment and management|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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