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Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Exercise Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
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
 Other: Exercise Intervention
Strength training and moderate-intensity, aerobic exercise


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in biomarker (IL-6) [ Time Frame: 12-weeks ]
  2. Changes in biomarker (TNF-a) [ Time Frame: 12-weeks ]
  3. Changes in biomarker (CRP) [ Time Frame: 12-weeks ]
  4. Changes in minutes of weekly physical activity [ Time Frame: 12-weeks ]
    7-Day Physical Activity Recall Interview

  5. Changes in waist to hip ratio [ Time Frame: 12-weeks ]
  6. Changes in weight (% change) [ Time Frame: 12-weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657628


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03657628    
Other Study ID Numbers: 18-168
1P50CA168504-05 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: October 17, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases