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Completed

NCT Number: NCT00801346

Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

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.

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Key information

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laboratory biomarker analysis

Other

metabolic assessment

Other

Questionnaire Administration

Other

assessment of therapy complications

Procedure

fatigue assessment and management

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. 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 outcomes

  1. Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months

  2. Family history as assessed by the Family History Questionnaire at baseline

  3. 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

  4. Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months

  5. Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months

  6. IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2008
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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