Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)] (WISER)
October 30, 2019 updated by: University of Minnesota
Women in Steady Exercise Research (WISER)
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.
Study Overview
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 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.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Saint Paul, Minnesota, United States, 55108
- University of Minnesota - St. Paul Campus
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: exercise
5 days per week exercise for 4 months
|
5 days per week exercise for 4 months
|
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NO_INTERVENTION: no exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in urine levels of F2-isoprostanes
Time Frame: Before and after study
|
Before and after study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in levels of IGF-axis proteins
Time Frame: Before and after study
|
Before and after study
|
|
Changes in insulin and glucose
Time Frame: Before and after study
|
Before and after study
|
|
Changes in estrogen metabolites
Time Frame: Before and after study
|
Before and after study
|
|
Changes in body composition
Time Frame: Before and after study
|
Before and after study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mindy Kurzer, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Crawford TN, Arikawa AY, Kurzer MS, Schmitz KH, Phipps WR. Cross-sectional study of factors influencing sex hormone-binding globulin concentrations in normally cycling premenopausal women. Fertil Steril. 2015 Dec;104(6):1544-51. doi: 10.1016/j.fertnstert.2015.08.040. Epub 2015 Sep 16.
- Arikawa AY, Jakits HE, Flood A, Thomas W, Gross M, Schmitz KH, Kurzer MS. Consumption of a high glycemic load but not a high glycemic index diet is marginally associated with oxidative stress in young women. Nutr Res. 2015 Jan;35(1):7-13. doi: 10.1016/j.nutres.2014.10.005. Epub 2014 Oct 16.
- Smith AJ, Phipps WR, Thomas W, Schmitz KH, Kurzer MS. The effects of aerobic exercise on estrogen metabolism in healthy premenopausal women. Cancer Epidemiol Biomarkers Prev. 2013 May;22(5):756-64. doi: 10.1158/1055-9965.EPI-12-1325.
- O'Dougherty M, Schmitz KH, Hearst MO, Covelli M, Kurzer MS. Dual conversations: body talk among young women and their social contacts. Qual Health Res. 2011 Sep;21(9):1191-204. doi: 10.1177/1049732311405804. Epub 2011 Apr 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
October 25, 2006
First Submitted That Met QC Criteria
October 25, 2006
First Posted (ESTIMATE)
October 26, 2006
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA00000312-5
- U54CA116849 (U.S. NIH Grant/Contract)
- UMN-0505M69867 (REGISTRY: University of Minnesota IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.