Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]
Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]
RATIONALE: Exercising regularly may lower the risk of breast cancer.

 PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer
 in healthy young women.
OBJECTIVES:

 Primary

 -  Compare the changes in urine levels of a stable marker of oxidative stress
 (F_2-isoprostanes) in healthy young women who undergo exercise training during 4
 menstrual cycles vs no exercise.

 Secondary

 -  Assess the changes in other metabolic factors that explain the association between
 physical activity and breast cancer, including:

 Estrogen metabolism (estrone, estradiol, estriol, 2-OHE_1, 2-OHE_2, 2-MeOHE_1, 2-MeOHE_2,
 4-OHE_1, 4-OHE_2 [as well as ratios of these metabolites], insulin-like growth factor (IGF)-1
 (as well as IGF-binding proteins-1, -2, and -3, insulin, glucose, body composition (including
 body mass index, lean mass, and body fat [DEXA scan]).

 OUTLINE: This is a randomized, controlled study. Participants are stratified according to
 baseline body fat percentage and age (18 to 24 years vs 25 to 30 years). Participants are
 randomized to 1 of 2 intervention arms.

 -  Arm I: Participants exercise for 30 minutes 5 times a week. The intensity of exercise is
 increased every 4 weeks. The exercise regimen continues for up to 4 menstrual cycles.

 -  Arm II: Participants are observed for 4 menstrual cycles. Participants in both arms
 undergo 24-hour collection of urine on days 7, 8, and 9 of menstrual cycles 1 and 6.
 F_2-isoprostanes are measured via gas chromatography-mass spectrometry (GC/MS).
 Estrogens are also measured by GC/MS and include E_1, E_2, E_3, 2-OHE_1, 2-OHE_2,
 4-OHE_1, 4-OHE_2, 2-MeE_1, 2-MeE_2, 4-MeE_1, 4-MeE_2, and 16OHE_1.

 Participants undergo blood collection, body mass measurement by dual-energy x-ray
 absorptiometry, and a fitness assessment twice during the 6-month study.

 PROJECTED ACCRUAL: A total of 400 participants will be accrued.
Inclusion Criteria:

 -  Healthy women

 -  Self-reported menstrual cycle length of 25-35 days within the past 2 months

 -  Nonsmoker

 -  Sedentary (exercise < 3 times weekly within the past 6 months)

 -  Intact ovaries and uterus

 -  No history of gynecological problems (e.g., fibroids, endometriosis, polycystic ovary
 syndrome)

 -  Female

 -  Premenopausal

 -  Body mass index 18.5 to 40

 -  Stable weight (no changes ≥ 10% within the past year)

 Exclusion Criteria:

 -  No pregnancy or breast feeding within the past 6 months

 -  No plans to become pregnant during study treatment

 -  No cancer within the past 5 years except for nonmelanoma skin cancers

 -  No medical condition that would prohibit participation in a vigorous program of
 weight-bearing aerobic exercise including, but not limited to, any of the following:

 -  Fibromyalgia

 -  Chronic fatigue syndrome

 -  Metabolic disorders

 -  Recent cardiovascular event

 -  Orthopedic limitations

 -  Psychiatric disorders requiring antipsychotic drugs

 -  No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg and/or
 diastolic BP > 99 mm Hg)

 -  No more than 7 alcoholic beverages per week

 -  No injected hormonal contraceptive use within the past year

 -  More than 6 months since prior use of intrauterine device

 -  More than 3 months since prior oral or patch hormone contraceptives

 -  No medication that would prohibit participation in a vigorous program of
 weight-bearing aerobic exercise