Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
18 Years
49 Years
Female
Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome
Trial Information
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
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
Outcome Time Frame:
within 12 months
Safety Issue:
No
Principal Investigator
Kenneth Oeffinger, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
07-092
NCT ID:
NCT00510315
Start Date:
July 2007
Completion Date:
July 2014
Related Keywords:
- Leukemia
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- Myelodysplastic Syndrome
- 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
- Hodgkin Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
- Preleukemia
- Obesity
- Obesity, Abdominal
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York, New York 10021 |
