search
Back to results

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
Vanderbilt University Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 2, 2008
Last Updated
April 20, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Cancer Institute (NCI)
search

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

We'll reach out to this number within 24 hrs