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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00510315

Collaborator

Queen's University, Kingston, Ontario (Other), Weill Medical College of Cornell University (Other)

Enrollment

Location

102

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Myelodysplastic Syndrome	Other: Questionnaires, Laboratory tests, Abdominal MRI

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Women treated with SCT/TBI	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
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	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

Arm

Intervention/Treatment

Women treated with SCT/TBI

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

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

Other: Questionnaires, Laboratory tests, Abdominal MRI

Outcome Measures

Primary Outcome Measures

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 [within 12 months]

Secondary Outcome Measures

Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups [within 12 months]
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. [within 12 months]
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. [within 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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