Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue



Status:Not yet recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 50
Updated:9/7/2018
Start Date:August 31, 2018
End Date:August 31, 2024
Contact:Jennifer Ligibel, MD
Email:Jennifer_Ligibel@dfci.harvard.edu
Phone:617-632-3800

Use our guide to learn which trials are right for you!

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

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.

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.

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)
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Jennifer Ligibel, MD
Phone: 617-632-3800
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials