Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant
3 de diciembre de 2020 actualizado por: Memorial Sloan Kettering Cancer Center
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
11
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 49 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Potential research subjects will be identified by a member of the research team from the SCT database and the medicine and pediatrics leukemia databases.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Women treated with SCT/TBI
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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
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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 |
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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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
Periodo de tiempo: within 12 months
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within 12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
Periodo de tiempo: within 12 months
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within 12 months
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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.
Periodo de tiempo: within 12 months
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within 12 months
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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.
Periodo de tiempo: within 12 months
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within 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kenneth Oeffinger, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de enero de 2016
Finalización del estudio (Actual)
1 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2007
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2007
Publicado por primera vez (Estimar)
2 de agosto de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de diciembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de diciembre de 2020
Última verificación
1 de diciembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Sobrenutrición
- Trastornos Nutricionales
- Condiciones precancerosas
- Obesidad
- Linfoma
- Síndromes mielodisplásicos
- Leucemia
- Enfermedad de Hodgkin
- Linfoma No Hodgkin
- Preleucemia
- Obesidad Abdominal
Otros números de identificación del estudio
- 07-092
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Ensayos clínicos sobre Questionnaires, Laboratory tests, Abdominal MRI
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Maastricht University Medical CenterTerminadoNeoplasias | Enfermedad Pulmonar Obstructiva Crónica | Neoplasias pancreáticas | CaquexiaPaíses Bajos