Metabolic Syndrome in Childhood Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00920738
First received: June 12, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Leukemia
Lymphoma
Metabolic Syndrome
Sarcoma
Other: metabolic assessment
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Syndrome in Childhood Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
  • Insulin resistance (IR) in CCS vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
  • Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
  • Dietary and a physical activity assessments of CCS vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

A 22 gauge intravenous polyethylene catheter will be inserted into an antecubital vein of one arm and the necessary blood for all baseline laboratory studies will be obtained and processed as per standard protocol.


Enrollment: 512
Study Start Date: April 2005
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920738

Locations
United States, Minnesota
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Julia Steinberger, MD, MS Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00920738     History of Changes
Other Study ID Numbers: 2003NT064, 0411M65666
Study First Received: June 12, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
metabolic syndrome
cancer survivor
childhood soft tissue sarcoma
unspecified childhood solid tumor, protocol specific
childhood acute lymphoblastic leukemia
childhood chronic myelogenous leukemia
childhood Hodgkin lymphoma
childhood non-Hodgkin lymphoma
childhood acute myeloid leukemia/other myeloid malignancies
chronic lymphocytic leukemia
childhood brain stem glioma
childhood cerebellar astrocytoma
childhood cerebral astrocytoma/malignant glioma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood embryonal tumor
childhood ependymoma
childhood oligodendroglioma
childhood pineal parenchymal tumor
childhood mixed glioma
childhood subependymal giant cell astrocytoma
childhood visual pathway and hypothalamic glioma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Metabolic Syndrome X
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on July 31, 2014