Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue (NCT03657628) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue
United States60 participantsStarted 2018-09-17
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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)