Clinical trial · Interventional
Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer
Women In Steady Exercise Research (WISER) Sister
NCT00892515CI-TRIAL-00044701completedN/AClinicalTrials.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: Exercise may change the risk of developing breast cancer. It is not yet known whether low-intensity exercise or high-intensity exercise is more effective in lowering the risk of breast cancer. PURPOSE: This randomized clinical trial is studying how well exercise programs work in healthy young women at increased risk of developing breast cancer.
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 |
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| dual x-ray absorptometry | Procedure | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| gas chromatography | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| mass spectrometry |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- exercise
- interventionNames
- Behavioral: exercise intervention
- Other: counseling intervention
- Other: gas chromatography
- Other: immunoenzyme technique
- Other: immunologic technique
- Other: laboratory biomarker analysis
- Other: mass spectrometry
- Other: physiologic testing
- Other: questionnaire administration
- Other: survey administration
- Procedure: dual x-ray absorptometry
- Procedure: magnetic resonance imaging
- Procedure: study of high risk factors
Primary outcomes (1)
- measure
- Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length
Secondary outcomes (4)
- measure
- Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Healthy women with ≥ 18% lifetime risk for breast cancer as evidenced by the following: * Documentation from a genetic counselor of a known familial breast cancer susceptibility mutation * Claus model risk of ≥18% * Predicted probability of BRCA1/2 mutation \> 25% based on the Myriad model * Documentation of a known mutation in a family member such that the Mendelian probability of a BRCA1/2 mutation would be \>25% * History of lobular carcinoma in situ * No prior prophylactic mastectomy * Leisure-time exercise energy expenditure of ≤ 500 kcal/week over the past 6 months * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Premenopausal * Menstrual cycles 25-32 days in length * Intact ovaries and uterus * Gynecologic age (defined as participant's current age minus the age at which she started menstruating) of at least 4 years * Body mass index 21-50 * No history of menstrual difficulties * No history of physician-diagnosed gynecological disease (e.g., fibroids, endometriosis, or polycystic ovary syndrome) * Not pregnant * Not planning to become pregnant during the study period * No medical conditions or medications that would prohibit participation in aerobic exercise or would negatively impact the study * No history of cancer, except nonmelanoma skin cancers, and in situ cervical cancers * No eating disorders (e.g., bulimia or binge-eating disorder) * At least one year since prior smoking * Not planning to move away from the area during the period of the study * No concurrent participation in any weight loss programs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 months since prior hormonal contraception * Must use effective non-hormonal contraception unless participant has undergone prior tubal ligation * Consumes no more than 7 alcoholic beverages per week
References
Publications (1)
- DERIVEDBoyer AL, Arikawa AY, Schmitz KH, Sturgeon KM. Association of Inflammatory Diets with Inflammatory Biomarkers in Women at High Genetic Risk for Breast Cancer. Nutr Cancer. 2022;74(3):816-819. doi: 10.1080/01635581.2021.1986554. Epub 2021 Oct 6. PMID 34615429