Metabolic Syndrome in Childhood Cancer Survivors

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Lymphoma; Leukemia; Metabolic Syndrome; Brain and Central Nervous System Tumors
• Intervention / Treatment: Other: metabolic assessment; Other: questionnaire administration

Detailed Description

OBJECTIVES:

Primary

• Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
• Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
• Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
• Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines [adiponectin, leptin], inflammatory mediators [e.g., interleukin-6], tumor necrosis factor-α, and C-reactive protein).
• Obtain dietary and physical activity assessments of CCS and healthy siblings.

Secondary

• Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.

OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.

Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Children's Hospital - Fairview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The childhood cancer survivor (CCS) subjects for this study will be selected from Pediatric Oncology databases at the University of Minnesota Medical Center and Children"s Hospitals and Clinics of Minneapolis and St. Paul as described previously. CCS will complete a comprehensive evaluation in the Masonic Clinical Research Unit (MCRU) over a 2 day time period. The comparative data on normal children and adolescents will be obtained from healthy siblings frequency matched by age and gender and who will be evaluated in a manner similar to the CCS.

Description

Inclusion Criteria:

• Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
• Subjects will be 9-17 years old at the time of their visit.
• Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.

Exclusion Criteria:

• Eligibility will not be restricted by race or sex.
• Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
• Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Survivors; Subjects who are cancer survivors must have survived childhood cancer (diagnosed < or = 18 years) for a minimum of 5 years and be in remission.	Other: metabolic assessment; Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc).; Other: questionnaire administration; Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2.; Other Names: MAQA; AQA
Healthy Siblings of Cancer Survivor; Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings.	Other: metabolic assessment; Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc).; Other: questionnaire administration; Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2.; Other Names: MAQA; AQA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls	Day 1 and Day 2
Insulin resistance (IR) in CCS vs controls	Day 1 and Day 2
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS	Day 1 and Day 2
Dietary and a physical activity assessments of CCS vs controls	Day 1 and Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS	Day 1 and Day 2

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: unspecified childhood solid tumor, protocol specific; cancer survivor; childhood chronic myelogenous leukemia; metabolic syndrome; chronic lymphocytic leukemia; childhood oligodendroglioma; childhood soft tissue sarcoma; childhood craniopharyngioma; childhood choroid plexus tumor; childhood acute lymphoblastic leukemia; childhood acute myeloid leukemia/other myeloid malignancies; childhood non-Hodgkin lymphoma; childhood pineal parenchymal tumor; childhood ependymoma; childhood mixed glioma; childhood cerebellar astrocytoma; childhood brain stem glioma; childhood visual pathway and hypothalamic glioma; childhood Hodgkin lymphoma; childhood cerebral astrocytoma/malignant glioma; childhood embryonal tumor; childhood subependymal giant cell astrocytoma
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Disease; Insulin Resistance; Hyperinsulinism; Sarcoma; Lymphoma; Syndrome; Leukemia; Metabolic Syndrome; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 2003NT064; 0411M65666 (Other Identifier: IRB, University of Minnesota)