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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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

UCSF Comprehensive Cancer Center, San Francisco, California, United States

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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

Physiologic Testing

Other

Questionnaire Administration

Other

breast imaging study

Procedure

dual x-ray absorptometry

Procedure

evaluation of cancer risk factors

Procedure

Magnetic Resonance Imaging

Procedure

Primary outcomes

  1. Mean serum progesterone level in women not using hormonal contraceptives

    Time frame: Day 1 of treatment

Secondary outcomes

  1. Luteal phase serum estradiol level in women not using hormonal contraceptives

    Time frame: Day 1 of treatment

  2. Bone mineral density of women who are not pregnant

    Time frame: Day 1 of treatment

  3. Breast density of women who are not pregnant

    Time frame: Day 1 of treatment

  4. Prevalence of metabolic syndrome

    Time frame: Day 1 of treatment

Sponsors 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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