Clinical trial · Interventional
Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue
Pilot Study of the Impact of a Physical Activity Intervention on Proliferation and Immune Markers in Benign Breast Tissue in Women With High Mammographic Breast Density
NCT03657628CI-TRIAL-00097842active not recruitingN/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)
This research study is evaluating the effect of exercise on markers in breast tissue and blood of premenopausal women who have been found to have dense breast tissue on mammogram.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Physical activity
- description
- * The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program. * Will receive social/behavioral support * Will receive research staff contact time to encourage them to increase their physical activity level * The participants will be given the option of a third supervised session each week
- interventionNames
- Other: Exercise Intervention
Primary outcomes (1)
- measure
- Impact of exercise upon expression of Ki-67
- timeFrame
- 12-weeks
- description
- To evaluate the change in breast tissue expression of Ki-67 in premenopausal women with increased breast density taking part in a 12-week physical activity intervention
Secondary outcomes (6)
- measure
- Changes in biomarker (IL-6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to any study-related procedures * Premenopausal women, defined as: * having regular menstrual cycles * age ≤ 50 years with an intact IUD * history of hysterectomy without oophorectomy * Heterogeneously dense or very dense (BIRADS 3 or 4) breast tissue on mammogram within the last 3 years * Physically inactive; engaging in \<90 minutes of moderate or vigorous intensity PA per week * No prior history of breast cancer * At least 18 years old * Physically able to exercise * English speaking and able to read English Exclusion Criteria: * Self-reported inability to walk 2 blocks (at any pace) * Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated. * On oral contraceptives; Mirena IUD is acceptable * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. * Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
References
Publications (0)
Data not yet available
No reference posted for this study.