Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children
|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.|
|ClinicalTrials.gov Identifier: NCT00458588|
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : April 6, 2017
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 or disease||Intervention/treatment|
|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|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||301 participants|
|Official Title:||Adolescent Diet, Hormones and Breast Cancer Susceptibility|
|Actual Study Start Date :||September 2006|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
- Mean serum progesterone level in women not using hormonal contraceptives [ Time Frame: Day 1 of treatment ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458588
|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|
|Study Chair:||Joanne Dorgan, PhD, MPH||Fox Chase Cancer Center|