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


N/A
18 Years
49 Years
Open (Enrolling)
Female
Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome

Thank you

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 AvenueNew York, New York  10021