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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

3 december 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

11

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10065
        • Memorial Sloan Kettering Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 49 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Potential research subjects will be identified by a member of the research team from the SCT database and the medicine and pediatrics leukemia databases.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Women treated with SCT/TBI
Övrig: 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
Övrig: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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
Tidsram: within 12 months
within 12 months

Sekundära resultatmått

Resultatmått
Tidsram
Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
Tidsram: within 12 months
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.
Tidsram: within 12 months
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.
Tidsram: within 12 months
within 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbetspartners

Weill Medical College of Cornell University
Queen's University, Kingston, Ontario

Utredare

  • Huvudutredare: Kenneth Oeffinger, MD, Memorial Sloan Kettering Cancer Center

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2007

Primärt slutförande (Faktisk)

1 januari 2016

Avslutad studie (Faktisk)

1 januari 2016

Studieregistreringsdatum

Först inskickad

31 juli 2007

Först inskickad som uppfyllde QC-kriterierna

1 augusti 2007

Första postat (Uppskatta)

2 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 december 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 december 2020

Senast verifierad

1 december 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 07-092

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