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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: October 25, 2006
Last updated: December 11, 2014
Last verified: December 2014

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 Intervention Phase
Breast Cancer
Behavioral: exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Women in Steady Exercise Research (WISER)

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

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

Enrollment: 400
Study Start Date: May 2006
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
5 days per week exercise for 4 months
Behavioral: exercise
5 days per week exercise for 4 months
No Intervention: no exercise

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.


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
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Please refer to this study by its identifier: NCT00393172

United States, Minnesota
University of Minnesota - St. Paul Campus
St. Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Principal Investigator: Mindy Kurzer University of Minnesota, MN
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00393172     History of Changes
Obsolete Identifiers: NCT00354718
Other Study ID Numbers: CDR0000511819
U54CA116849 ( US NIH Grant/Contract Award Number )
UMN-0505M69867 ( Registry Identifier: University of Minnesota IRB )
Study First Received: October 25, 2006
Last Updated: December 11, 2014

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
breast cancer
estrogen metabolism
oxidative stress

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017