Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Queen's University, Kingston, Ontario
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00510315
First received: July 31, 2007
Last updated: April 23, 2014
Last verified: April 2014

July 31, 2007
April 23, 2014
July 2007
July 2015   (final data collection date for primary outcome measure)
Explore whether visceral adipose tissue is significantly higher in women who were treated with total body irradiation (TBI) plus stem cell transplant in comparison with women who were not [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00510315 on ClinicalTrials.gov Archive Site
  • Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
  • Determine the correlation between the amount of visceral adipose tissue and fasting levels of triglycerides, LDL, HDL, insulin, glucose, and HOMA-IR in both groups. [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
  • To begin to characterize the psychosocial risk factors of the TBI plus stem cell transplant group, in relation to the comparison group, in order to inform a future targeted intervention to reduce risk. [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
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Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant

The purpose of this study is to better understand why some women who survived cancer or a related illness later develop diabetes, problems with their cholesterol, or other problems that may lead to heart disease. Because these problems may be related to treatment with total body irradiation and a stem cell transplant, the investigators will compare the rates of obesity, cholesterol problems, and diabetes between women who were treated with total body irradiation and a stem cell transplant and women who were not.

The amount and location of fat stores in the abdomen is more important than overall weight or total body fat in the development of diabetes and cholesterol problems. In general, fat can be stored in several areas in the abdomen: around the organs (visceral fat), under the skin (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around the organs (visceral fat), even those with a normal weight, are more likely to become diabetic or have high cholesterol. The amount of fat in each of these areas can be measured with an abdominal magnetic resonance imaging (MRI).

In this study, the investigators will use blood tests, height, weight, waist circumference, blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood pressure, and increased abdominal fat.

We will enroll 60 female participants in this study. From the population of interest, female cancer survivors (or women treated for a related illness) who were treated with TBI prior to a SCT, we will enroll 30 participants, 10 from each of the following cancer groups: acute lymphoblastic leukemia, acute myeloid leukemia, and chronic myeloid leukemia. We are interested in determining the outcomes in adult survivors who have completed their growth by the time of study and yet are younger than the age when most women generally begin to develop insulin resistance or dyslipidemia in the general population. For this reason, we will enroll women who are 18 - 49 years of age at the time of study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Non-Probability Sample

Potential research subjects will be identified by a member of the research team from the SCT database and the medicine and pediatrics leukemia databases.

  • Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Myelodysplastic Syndrome
Other: Questionnaires, Laboratory tests, Abdominal MRI
Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement
  • Women treated with SCT/TBI
    Intervention: Other: Questionnaires, Laboratory tests, Abdominal MRI
  • 1:1 Matched group of women

    Current age + or - 2 years

    Race and ethnicity

    Cancer diagnosis

    Interval from completion of cancer therapy to study + or - 2 years

    Intervention: Other: Questionnaires, Laboratory tests, Abdominal MRI
Oeffinger KC, Adams-Huet B, Victor RG, Church TS, Snell PG, Dunn AL, Eshelman-Kent DA, Ross R, Janiszewski PM, Turoff AJ, Brooks S, Vega GL. Insulin resistance and risk factors for cardiovascular disease in young adult survivors of childhood acute lymphoblastic leukemia. J Clin Oncol. 2009 Aug 1;27(22):3698-704. Epub 2009 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Target population

  • Females 18 - 49 years of age at time of study
  • Previous diagnosis of ALL, AML, CML, CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
  • Previously treated with TBI (1200 - 1500 cGy) prior to SCT
  • Free of cancer
  • Two years or more from completion of cancer therapy
  • Able and willing to give informed consent

Comparison group

  • Females 18 - 49 years of age at time of study
  • Previous diagnosis of ALL, AML, CML CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
  • Free of cancer
  • Two years or more from completion of cancer therapy
  • Able and willing to give informed consent

Exclusion Criteria:

Target population

  • Pregnant at time of study
  • Previous cranial radiotherapy (other than TBI)
  • Second primary malignancy (other than non-melanoma skin cancer)
  • Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
  • Currently on a medication for diabetes mellitus or dyslipidemia
  • Patients with a creatinine > 1.5 mg/dL or biopsy-proven chronic active hepatitis
  • Contraindication to an MRI

Comparison group

  • pregnant at time of study
  • Previous cranial radiotherapy
  • Second primary malignancy (other than non-melanoma skin cancer)
  • Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
  • Currently on a medication for diabetes mellitus or dyslipidemia
  • Patients with a creatinine > 1.5 or biopsy-proven chronic active hepatitis
  • Contraindication to an MRI
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510315
07-092
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Queen's University, Kingston, Ontario
  • Weill Medical College of Cornell University
Principal Investigator: Kenneth Oeffinger, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP