Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Women in Steady Exercise Research (WISER)

Conditions
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Breast Cancer, Obesity

Intervention / Treatment
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* Behavioral: exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>5 days per week exercise for 4 months | Behavioral: exercise<br>* 5 days per week exercise for 4 months<br>|
| No Intervention: no exercise<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urine levels of F2-isoprostanes |  | Before and after study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of IGF-axis proteins |  | Before and after study | 
| Changes in insulin and glucose |  | Before and after study | 
| Changes in estrogen metabolites |  | Before and after study | 
| Changes in body composition |  | Before and after study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IGF-1, exercise, breast cancer, prevention, obesity, estrogen metabolism, oxidative stress