Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children

Breast Cancer Clinical Trial

Official title:

Adolescent Diet, Hormones and Breast Cancer Susceptibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458588
• Other study ID #: CDR0000538232
• Secondary ID: R01CA104670P30CA
• Status: Completed
• Phase: N/A
• First received: April 9, 2007
• Last updated: April 5, 2017
• Start date: September 2006
• Est. completion date: October 2013

Study information

• Verified date: April 2017
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• physiologic testing

• questionnaire administration

Procedure:
• breast imaging study

• dual x-ray absorptometry

• evaluation of cancer risk factors

• magnetic resonance imaging

Locations

Country	Name	City	State
United States	Maryland Medical Research Institute	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
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	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Children's Hospital of New Orleans	New Orleans	Louisiana
United States	UMDNJ University Hospital	Newark	New Jersey
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean serum progesterone level in women not using hormonal contraceptives		Day 1 of treatment
Secondary	Luteal phase serum estradiol level in women not using hormonal contraceptives		Day 1 of treatment
Secondary	Bone mineral density of women who are not pregnant		Day 1 of treatment
Secondary	Breast density of women who are not pregnant		Day 1 of treatment
Secondary	Prevalence of metabolic syndrome		Day 1 of treatment