Clinical trial NCT00458588: Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children
Official title: Adolescent Diet, Hormones and Breast Cancer Susceptibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-11
Enrollment: 301
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent females

Brief summary: RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral density, and breast density later in life. This may affect the risk of developing breast cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density, and breast density may help the study of breast cancer in the future.

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.

Detailed description: OBJECTIVES:

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children"

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Mean serum progesterone level in women not using hormonal contraceptives
timeFrame: Day 1 of treatment
Secondary outcomes:
measure: Luteal phase serum estradiol level in women not using hormonal contraceptives
timeFrame: Day 1 of treatment
measure: Bone mineral density of women who are not pregnant
timeFrame: Day 1 of treatment
measure: Breast density of women who are not pregnant
timeFrame: Day 1 of treatment
measure: Prevalence of metabolic syndrome
timeFrame: Day 1 of treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Medical Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Newark
country: United States
facility: UMDNJ University Hospital
state: New Jersey
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Joanne Dorgan, PhD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.