Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801346
• Other study ID #: CDR0000624471
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: April 20, 2017
• Start date: November 2008
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Leukemia
• Leukemia, Lymphoid
• Long-term Effects Secondary to Cancer Therapy in Children
• Metabolic Syndrome X
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• laboratory biomarker analysis

• metabolic assessment

• questionnaire administration

Procedure:
• assessment of therapy complications

• fatigue assessment and management

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
Secondary	Family history as assessed by the Family History Questionnaire at baseline
Secondary	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
Secondary	Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
Secondary	Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
Secondary	IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months