Clinical trial NCT00510315: Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Queen's University, Kingston, Ontario
name: Weill Medical College of Cornell University
First posted: 2007-08-02
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: within 12 months
Secondary outcomes:
measure: Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
timeFrame: within 12 months
measure: 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.
timeFrame: within 12 months
measure: 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.
timeFrame: within 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Oeffinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.