Status:
COMPLETED
Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
18-30 years
Phase:
PHASE2
PHASE3
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00393172
Start Date
May 1 2006
End Date
March 1 2010
Last Update
November 1 2019
Active Locations (1)
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1
University of Minnesota - St. Paul Campus
Saint Paul, Minnesota, United States, 55108