Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

Study Overview
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Brief Summary
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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.

Detailed Description
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Women who exercise regularly have a lower risk of developing breast cancer, but the processes through which exercise could make cancer less likely to occur are not known. Some research in animals has shown that exercise can slow the growth of breast cancer cells and may increase the body's own defense mechanisms by stimulating the immune system. Very little is known about the effects of exercise on breast tissue in people. Understanding what changes occur in breast tissue and related markers in blood when a woman begins to exercise could provide more information about the ways in which exercise could prevent breast cancer. The study is designed to look at the changes that occur in markers found in breast tissue and blood in women with dense breast tissue who take part in an exercise program. Density of breast tissue is a measure of how much of the breast tissue is made up of cells rather than fat. Breast density on mammogram has been linked to the risk of developing breast cancer, with women with higher degrees of breast density having a higher risk of developing breast cancer compared to women whose breasts are less dense. Since the investigators do not know if these blood or breast tissue tests have any relationship to the development of breast cancer, the investigators do not plan to share the results of these tests with the participant or its physician. The investigators will give the participants the option of receiving the overall study results when the trial is completed, if the participant would like to receive them.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>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 | Other: Exercise Intervention<br>* Strength training and moderate-intensity, aerobic exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of exercise upon expression of Ki-67 | 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 | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in biomarker (IL-6) |  | 12-weeks | 
| Changes in biomarker (TNF-a) |  | 12-weeks | 
| Changes in biomarker (CRP) |  | 12-weeks | 
| Changes in minutes of weekly physical activity | 7-Day Physical Activity Recall Interview | 12-weeks | 
| Changes in waist to hip ratio |  | 12-weeks | 
| Changes in weight (% change) |  | 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer