Clinical trial NCT00801346: 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
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-03
Enrollment: 224
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

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.

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)

Primary outcomes:
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)
Secondary outcomes:
measure: Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
measure: Family history as assessed by the Family History Questionnaire at baseline
measure: 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
measure: Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
measure: Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
measure: IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Adam J. Esbenshade, MD
role: PRINCIPAL_INVESTIGATOR
References: