Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

This study is currently recruiting participants.
Verified November 2008 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00801346
First received: December 2, 2008
Last updated: August 11, 2009
Last verified: November 2008

December 2, 2008
August 11, 2009
November 2008
January 2015   (final data collection date for 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) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00801346 on ClinicalTrials.gov Archive Site
  • Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Family history as assessed by the Family History Questionnaire at baseline [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months [ Designated as safety issue: No ]
Same as current
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Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
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.

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.
Observational
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  • Fatigue
  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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January 2015   (final data collection date for primary outcome measure)

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)
Both
1 Year to 20 Years
No
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United States
 
NCT00801346
CDR0000624471, VU-VICC-PED-0872, IRB# 081043
Not Provided
Adam J. Esbenshade, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigator: Kathleen M. Von Wahlde Vanderbilt-Ingram Cancer Center
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP