NCT Number: NCT00458588
Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children
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.
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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Observational
Primary location
UCSF Comprehensive Cancer Center, San Francisco, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children"
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Treatment and study plan
Questionnaire Administration
Otherbreast imaging study
Proceduredual x-ray absorptometry
Procedureevaluation of cancer risk factors
ProcedureMagnetic Resonance Imaging
ProcedurePrimary outcomes
-
Mean serum progesterone level in women not using hormonal contraceptives
Time frame: Day 1 of treatment
Secondary outcomes
-
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
Interested in participating?
Looking for future studies?
Notify MeSponsors and collaborators
Lead sponsor
Fox Chase Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Adolescent Diet, Hormones and Breast Cancer Susceptibility
Important dates
- Study start
- 2006
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 11, 2007
- Registry last updated
- Apr 6, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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