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Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801346
First Posted: December 3, 2008
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt University Medical Center
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Official Title: The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).

Resource links provided by NLM:


Further study details as provided by Adam Esbenshade, Vanderbilt University Medical Center:

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

Enrollment: 224
Study Start Date: November 2008
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801346


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Adam Esbenshade, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00801346     History of Changes
Other Study ID Numbers: CDR0000624471
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-PED-0872
IRB# 081043
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by Adam Esbenshade, Vanderbilt University Medical Center:
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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Metabolic Syndrome X
Fatigue
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms