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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393172
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : November 1, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Obesity Behavioral: exercise Phase 2 Phase 3

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Women in Steady Exercise Research (WISER)
Study Start Date : May 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: exercise
5 days per week exercise for 4 months
Behavioral: exercise
5 days per week exercise for 4 months

No Intervention: no exercise

Primary Outcome Measures :
  1. Changes in urine levels of F2-isoprostanes [ Time Frame: Before and after study ]

Secondary Outcome Measures :
  1. Changes in levels of IGF-axis proteins [ Time Frame: Before and after study ]
  2. Changes in insulin and glucose [ Time Frame: Before and after study ]
  3. Changes in estrogen metabolites [ Time Frame: Before and after study ]
  4. Changes in body composition [ Time Frame: Before and after study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393172

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United States, Minnesota
University of Minnesota - St. Paul Campus
Saint Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota
National Cancer Institute (NCI)
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Principal Investigator: Mindy Kurzer University of Minnesota
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Minnesota Identifier: NCT00393172    
Obsolete Identifiers: NCT00354718
Other Study ID Numbers: FWA00000312-5
U54CA116849 ( U.S. NIH Grant/Contract )
UMN-0505M69867 ( Registry Identifier: University of Minnesota IRB )
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by University of Minnesota:
breast cancer
estrogen metabolism
oxidative stress
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight