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Women in Steady Exercise Research (WISER)

Phase 2/Phase 3
18 Years
30 Years
Not Enrolling
Breast Cancer, Obesity

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Trial Information

Women in Steady Exercise Research (WISER)



- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Changes in urine levels of F2-isoprostanes

Outcome Time Frame:

Before and after study

Safety Issue:


Principal Investigator

Mindy Kurzer

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2006

Completion Date:

March 2010

Related Keywords:

  • Breast Cancer
  • Obesity
  • exercise
  • breast cancer
  • prevention
  • obesity
  • estrogen metabolism
  • oxidative stress
  • IGF-1
  • Breast Neoplasms
  • Obesity



University of Minnesota - St. Paul Campus St. Paul, Minnesota  55108