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Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in biomarker (IL-6)
Changes in biomarker (TNF-a)
Changes in biomarker (CRP)
Changes in minutes of weekly physical activity
7-Day Physical Activity Recall Interview
Changes in waist to hip ratio
Changes in weight (% change)

Full Information

First Posted
August 24, 2018
Last Updated
October 16, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03657628
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Strength training and moderate-intensity, aerobic exercise
Primary Outcome Measure Information:
Title
Impact of exercise upon expression of Ki-67
Description
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
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Changes in biomarker (IL-6)
Time Frame
12-weeks
Title
Changes in biomarker (TNF-a)
Time Frame
12-weeks
Title
Changes in biomarker (CRP)
Time Frame
12-weeks
Title
Changes in minutes of weekly physical activity
Description
7-Day Physical Activity Recall Interview
Time Frame
12-weeks
Title
Changes in waist to hip ratio
Time Frame
12-weeks
Title
Changes in weight (% change)
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

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