LeukemiaNCT00510315
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant
An observational study of Leukemia and Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- Questionnaires, Laboratory tests, Abdominal MRI
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the 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.
- Being tested
- Questionnaires, Laboratory tests, Abdominal MRI
- Keywords
- 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
- Medical subject headings
- Leukemia, Hodgkin Disease, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms, Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, Laboratory tests, Abdominal MRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| Women treated with SCT/TBI | Not described Receives: Other: Questionnaires, Laboratory tests, Abdominal MRI | |
| 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 Receives: Other: Questionnaires, Laboratory tests, Abdominal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 12 months
Secondary outcomes (3)
Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
Measured: within 12 months
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.
Measured: within 12 months
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.
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Kenneth Oeffinger, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510315
- Sponsor's protocol ID
- 07-092
- Status last verified
- Dec 2020
- First submitted
- 31 Jul 2007
- Last updated
- 7 Dec 2020
- Results posted
- No
Publications
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.
PubMed 19564534
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00510315
- Acronym / sponsor ID
- 07-092
- Keywords
- leukemia, survivors, women, leukemia survivors, cancer or a related illness, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, myelodysplastic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario, Weill Medical College of Cornell University
- Study start
- Jul 2007
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women treated with SCT/TBI | – | Other: Questionnaires, Laboratory tests, Abdominal MRI |
| 1:1 Matched group of women | – | Other: Questionnaires, Laboratory tests, Abdominal MRICurrent age + or - 2 years Race and ethnicity Cancer diagnosis Interval from completion of cancer therapy to study + or - 2 years |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires, Laboratory tests, Abdominal MRIHeight, 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 | Other | 1:1 Matched group of women, Women treated with SCT/TBI |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Background: PubMed 19564534Oeffinger 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Oeffinger, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.