Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children
- Conditions
- Breast Cancer
- Registration Number
- NCT00458588
- Lead Sponsor
- Fox Chase Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 301
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean serum progesterone level in women not using hormonal contraceptives Day 1 of treatment
- Secondary Outcome Measures
Name Time Method Luteal phase serum estradiol level in women not using hormonal contraceptives Day 1 of treatment Bone mineral density of women who are not pregnant Day 1 of treatment Breast density of women who are not pregnant Day 1 of treatment Prevalence of metabolic syndrome Day 1 of treatment
Trial Locations
- Locations (10)
Kaiser Permanente Center for Health Research
🇺🇸Portland, Oregon, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Maryland Medical Research Institute
🇺🇸Baltimore, Maryland, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
UMDNJ University Hospital
🇺🇸Newark, New Jersey, United States