Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

• ClinicalTrials.gov Identifier: NCT03657628
• Recruitment Status: Active, not recruiting
• First Posted: September 5, 2018
• Last Update Posted: October 17, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 24, 2018
• First Posted Date: September 5, 2018
• Last Update Posted Date: October 17, 2023
• Actual Study Start Date: September 17, 2018
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2018)

Impact of exercise upon expression of Ki-67 [ Time Frame: 12-weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 1, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue
• 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
• Brief 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Breast Cancer

Intervention

Other: Exercise Intervention

Strength training and moderate-intensity, aerobic exercise

Study Arms

Experimental: Physical activity

• 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

Intervention: Other: Exercise Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 1, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03657628
• Other Study ID Numbers: 18-168; 1P50CA168504-05 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer Ligibel, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2023