Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00801346

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Fatigue Leukemia	Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: laboratory biomarker analysis Procedure: metabolic abnormality assessment Procedure: quality-of-life assessment Procedure: questionnaire administration	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
Family history as assessed by the Family History Questionnaire at baseline [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months [ Designated as safety issue: No ]
IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	November 2008
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	1 Year to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801346

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Adam Esbenshade 615-936-1762
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Adam Esbenshade 615-936-1762
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Investigator:	Kathleen M. Von Wahlde	Vanderbilt-Ingram Cancer Center
Principal Investigator:	Adam J. Esbenshade, MD	Vanderbilt-Ingram Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt-Ingram Cancer Center ( Adam J. Esbenshade )
Study ID Numbers:	CDR0000624471, VU-VICC-PED-0872, IRB# 081043
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801346
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Lymphatic Diseases
Signs and Symptoms
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Fatigue
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm Metastasis
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009