Know Cancer

or
forgot password

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


Phase 1
1 Year
20 Years
Open (Enrolling)
Both
Fatigue, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Observational

Study Design:

N/A

Outcome 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)

Safety Issue:

No

Principal Investigator

Kathleen M. Von Wahlde

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

Unspecified

Study ID:

CDR0000624471

NCT ID:

NCT00801346

Start Date:

November 2008

Completion Date:

Related Keywords:

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

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064