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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00458588
First received: April 9, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Other: physiologic testing
Other: questionnaire administration
Procedure: breast imaging study
Procedure: dual x-ray absorptometry
Procedure: evaluation of cancer risk factors
Procedure: magnetic resonance imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Adolescent Diet, Hormones and Breast Cancer Susceptibility

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Mean serum progesterone level in women not using hormonal contraceptives

Secondary Outcome Measures:
  • Luteal phase serum estradiol level in women not using hormonal contraceptives
  • Bone mineral density of women who are not pregnant
  • Breast density of women who are not pregnant
  • Prevalence of metabolic syndrome

Estimated Enrollment: 301
Study Start Date: September 2005
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adolescent females

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458588

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maryland
Maryland Medical Research Institute
Baltimore, Maryland, United States, 21210
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
UMDNJ University Hospital
Newark, New Jersey, United States, 07107
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Joanne Dorgan, PhD, MPH Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided by Fox Chase Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00458588     History of Changes
Other Study ID Numbers: CDR0000538232, R01CA104670, P30CA006927, FCCC-9305, FCCC-IRB-05-843
Study First Received: April 9, 2007
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014