Know Cancer

or
forgot password

Adolescent Diet, Hormones and Breast Cancer Susceptibility


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Adolescent Diet, Hormones and Breast Cancer Susceptibility


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Mean serum progesterone level in women not using hormonal contraceptives

Principal Investigator

Joanne Dorgan, PhD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000538232

NCT ID:

NCT00458588

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Kaiser Permanente Center for Health ResearchPortland, Oregon  97227-1098
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
UMDNJ University HospitalNewark, New Jersey  07103
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Maryland Medical Research InstituteBaltimore, Maryland  21210