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Completed

NCT Number: NCT00510315

Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following 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.

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Key information

Conditions

Leukemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires, Laboratory tests, Abdominal MRI

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Queen's University, Kingston, Ontario
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2007
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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