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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458588
First Posted: April 11, 2007
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
  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: Observational Model: Other
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 [ Time Frame: Day 1 of treatment ]

Secondary Outcome Measures:
  • Luteal phase serum estradiol level in women not using hormonal contraceptives [ Time Frame: Day 1 of treatment ]
  • Bone mineral density of women who are not pregnant [ Time Frame: Day 1 of treatment ]
  • Breast density of women who are not pregnant [ Time Frame: Day 1 of treatment ]
  • Prevalence of metabolic syndrome [ Time Frame: Day 1 of treatment ]

Estimated Enrollment: 301
Actual Study Start Date: September 2006
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Joanne Dorgan, PhD, MPH Fox Chase Cancer Center
  More Information

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 ( U.S. NIH Grant/Contract )
P30CA006927 ( U.S. NIH Grant/Contract )
FCCC-9305
FCCC-IRB-05-843
First Submitted: April 9, 2007
First Posted: April 11, 2007
Last Update Posted: April 6, 2017
Last Verified: April 2017

Keywords provided by Fox Chase Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs