Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)] (WISER)
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00393172
First received: October 25, 2006
Last updated: November 8, 2010
Last verified: November 2010
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Purpose
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 Obesity |
Behavioral: exercise |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Women in Steady Exercise Research (WISER) |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Diabetes Medicines
Exercise and Physical Fitness
Obesity
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in levels of IGF-axis proteins [ Time Frame: Before and after study ] [ Designated as safety issue: No ]
- Changes in insulin and glucose [ Time Frame: Before and after study ] [ Designated as safety issue: No ]
- Changes in estrogen metabolites [ Time Frame: Before and after study ] [ Designated as safety issue: No ]
- Changes in body composition [ Time Frame: Before and after study ] [ Designated as safety issue: No ]
| 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:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393172
Locations
| 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
Investigators
| Principal Investigator: | Mindy Kurzer | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided by University of Minnesota - Clinical and Translational Science Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mindy Kurzer, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00393172 History of Changes |
| Obsolete Identifiers: | NCT00354718 |
| Other Study ID Numbers: | CDR0000511819, U54CA116849, UMN-0505M69867 |
| Study First Received: | October 25, 2006 |
| Last Updated: | November 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
exercise breast cancer prevention obesity |
estrogen metabolism oxidative stress IGF-1 |
Additional relevant MeSH terms:
|
Breast Neoplasms Obesity Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013