Clinical trial · Interventional
Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]
Women in Steady Exercise Research (WISER)
NCT00393172CI-TRIAL-00041394WISERcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- exercise
- description
- 5 days per week exercise for 4 months
- interventionNames
- Behavioral: exercise
- type
- NO_INTERVENTION
- label
- no exercise
Primary outcomes (1)
- measure
- Changes in urine levels of F2-isoprostanes
- timeFrame
- Before and after study
Secondary outcomes (4)
- measure
- Changes in levels of IGF-axis proteins
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDCrawford 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. PMID 26385402
- DERIVEDArikawa 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. PMID 25453541
- DERIVEDSmith 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. PMID 23652373
- DERIVEDO'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. PMID 21508251