Breast Cancer Clinical Trial
Official title:
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
Verified date | October 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Changes in biomarker (IL-6) | 12-weeks | ||
Secondary | Changes in biomarker (TNF-a) | 12-weeks | ||
Secondary | Changes in biomarker (CRP) | 12-weeks | ||
Secondary | Changes in minutes of weekly physical activity | 7-Day Physical Activity Recall Interview | 12-weeks | |
Secondary | Changes in waist to hip ratio | 12-weeks | ||
Secondary | Changes in weight (% change) | 12-weeks |
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