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

NCT ID: NCT00510315

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women treated with SCT/TBI

Questionnaires, Laboratory tests, Abdominal MRI

Intervention Type 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

Current age + or - 2 years

Race and ethnicity

Cancer diagnosis

Interval from completion of cancer therapy to study + or - 2 years

Questionnaires, Laboratory tests, Abdominal MRI

Intervention Type 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

Interventions

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Questionnaires, Laboratory tests, Abdominal MRI

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Queen's University, Kingston, Ontario

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Oeffinger, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19564534 (View on PubMed)

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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07-092

Identifier Type: -

Identifier Source: org_study_id