Trial record 3 of 266 for:    Lymphoma AND (women OR woman OR female)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Queen's University, Kingston, Ontario
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00510315
First received: July 31, 2007
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Leukemia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Myelodysplastic Syndrome
Other: Questionnaires, Laboratory tests, Abdominal MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: within 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: within 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 11
Study Start Date: July 2007
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women treated with SCT/TBI Other: 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
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

Other: 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

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510315

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Queen's University, Kingston, Ontario
Weill Medical College of Cornell University
Investigators
Principal Investigator: Kenneth Oeffinger, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00510315     History of Changes
Other Study ID Numbers: 07-092
Study First Received: July 31, 2007
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
women
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
leukemia
survivors
leukemia survivors
cancer or a related illness
myelodysplastic syndrome
aplastic anemia
treated with total body irradiation
followed by an allogeneic or autologous stem cell transplant

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Hodgkin Disease
Obesity, Abdominal
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014