Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

Vanderbilt University Medical Center

Status: Completed

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

Treatments: Procedure: assessment of therapy complications; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: metabolic assessment; Procedure: fatigue assessment and management

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00801346

P30CA068485 (U.S. NIH Grant/Contract)

IRB# 081043

VU-VICC-PED-0872

CDR0000624471

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)