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

NCT00510315 | Completed

• 1 other identifier: 07-092
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Myelodysplastic Syndrome

Keywords

leukemia; survivors; women; leukemia survivors; cancer or a related illness; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; myelodysplastic syndrome; aplastic anemia; treated with total body irradiation; followed by an allogeneic or autologous stem cell transplant

Outcome Measures

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

  within 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Women treated with SCT/TBI

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

Other: Questionnaires, Laboratory tests, Abdominal MRI

Interventions

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

1:1 Matched group of women; Women treated with SCT/TBI

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Queen's University, Kingston, Ontario: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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. doi: 10.1200/JCO.2008.19.7251. Epub 2009 Jun 29.

  PMID: 19564534 BACKGROUND

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Leukemia; Hodgkin Disease; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Neoplasms; Anemia, Aplastic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Anemia; Bone Marrow Failure Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kenneth Oeffinger, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

US (1)