Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children
NCT ID: NCT00458588
Last Updated: 2017-04-06
Study Results
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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COMPLETED
301 participants
OBSERVATIONAL
2006-09-30
2013-10-31
Brief Summary
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PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the Dietary Intervention Study in Children.
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Detailed Description
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Primary
* Determine the long-term effect of the Dietary Intervention Study in Children (DISC) to lower total fat and saturated fat intake during adolescence on serum progesterone levels in young women previously enrolled in the DISC study.
Secondary
* Determine the long-term effect of the DISC intervention on serum estradiol levels in these women.
* Determine the long-term effect of the DISC intervention on bone mineral density in these women.
* Determine the long-term effect of the DISC intervention on breast density in these women.
* Determine the long-term effect of the DISC intervention on the prevalence of metabolic syndrome in these women.
OUTLINE: This is a multicenter study.
Patients undergo fasting blood collection on day 1 for assessment of serum hormones (progesterone, estradiol), lipids, lipoproteins, and fasting glucose. Patients also undergo blood pressure, height, weight, and waist circumference measurements. Patient then receive a snack and complete the Modifiable Activity questionnaire, Center for Epidemiological Studies Depression Scale short form, Spielberger State-Trait Anxiety Inventory, and Dietary Intervention Study in Children Medical History questionnaire (including demographics, medical history, menstrual history, medications, reproductive history, dietary supplements, alcohol and tobacco use, and family history of cancer). Patients also undergo dual-energy x-ray absorptiometry (DEXA) and MRI to measure bone and breast density. Patients complete an in-person 24-hour dietary recall using the Nutrition Data System for Research on day 1 and via telephone once in weeks 2 and 3.
Day 1 is scheduled during the patient's luteal phase of menstrual cycle. After completion of study, patients contact the clinic to report start of next menses.
PROJECTED ACCRUAL: A total of 301 patients will be accrued for this study.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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physiologic testing
questionnaire administration
breast imaging study
dual x-ray absorptometry
evaluation of cancer risk factors
magnetic resonance imaging
Eligibility Criteria
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Inclusion Criteria
* Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children"
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joanne Dorgan, PhD, MPH
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Maryland Medical Research Institute
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
UMDNJ University Hospital
Newark, New Jersey, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Jung S, Goloubeva O, Hylton N, Klifa C, LeBlanc E, Shepherd J, Snetselaar L, Van Horn L, Dorgan JF. Intake of dietary carbohydrates in early adulthood and adolescence and breast density among young women. Cancer Causes Control. 2018 Jul;29(7):631-642. doi: 10.1007/s10552-018-1040-1. Epub 2018 May 25.
Bertrand KA, Baer HJ, Orav EJ, Klifa C, Kumar A, Hylton NM, LeBlanc ES, Snetselaar LG, Van Horn L, Dorgan JF. Early Life Body Fatness, Serum Anti-Mullerian Hormone, and Breast Density in Young Adult Women. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1151-7. doi: 10.1158/1055-9965.EPI-16-0185. Epub 2016 May 9.
Bertrand KA, Baer HJ, Orav EJ, Klifa C, Shepherd JA, Van Horn L, Snetselaar L, Stevens VJ, Hylton NM, Dorgan JF. Body fatness during childhood and adolescence and breast density in young women: a prospective analysis. Breast Cancer Res. 2015 Jul 16;17(1):95. doi: 10.1186/s13058-015-0601-4.
Jung S, Egleston BL, Chandler DW, Van Horn L, Hylton NM, Klifa CC, Lasser NL, LeBlanc ES, Paris K, Shepherd JA, Snetselaar LG, Stanczyk FZ, Stevens VJ, Dorgan JF. Adolescent endogenous sex hormones and breast density in early adulthood. Breast Cancer Res. 2015 Jun 4;17(1):77. doi: 10.1186/s13058-015-0581-4.
Jung S, Stanczyk FZ, Egleston BL, Snetselaar LG, Stevens VJ, Shepherd JA, Van Horn L, LeBlanc ES, Paris K, Klifa C, Dorgan JF. Endogenous sex hormones and breast density in young women. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):369-78. doi: 10.1158/1055-9965.EPI-14-0939. Epub 2014 Nov 4.
Dorgan JF, Liu L, Barton BA, Deshmukh S, Snetselaar LG, Van Horn L, Stevens VJ, Robson AM, Lasser NL, Himes JH, Shepherd JA, Pourfarzib R, Pettee Gabriel K, Kriska A, Kwiterovich PO Jr. Adolescent diet and metabolic syndrome in young women: results of the Dietary Intervention Study in Children (DISC) follow-up study. J Clin Endocrinol Metab. 2011 Dec;96(12):E1999-2008. doi: 10.1210/jc.2010-2726. Epub 2011 Oct 12.
Other Identifiers
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FCCC-9305
Identifier Type: -
Identifier Source: secondary_id
FCCC-IRB-05-843
Identifier Type: -
Identifier Source: secondary_id
CDR0000538232
Identifier Type: -
Identifier Source: org_study_id
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