The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. The names of the study groups in this study are: * Exercise Training Group * Waitlist Control Group
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance. The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires. Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity. Participants will be in this research study for up to 16 weeks. It is expected that 46 women will take part in this study. The Breast Cancer Research Foundation is supporting this research study by providing funding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study.
Brigham and Women's Hospital
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGChange in Irisin in Exercise Group
Change in circulating irisin at baseline, after 1st exercise session, and end of study in exercise group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.
Time frame: At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks
Change in Irisin in Control Group
Change in circulating irisin at baseline and end of study in control group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.
Time frame: At baseline and week 12, up to 16 weeks
Change in Tissue Markers in Exercise Group
Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute.
Time frame: At baseline and week 12, up to 16 weeks
Change in Tissue Markers in Control Group
Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute.
Time frame: At baseline and week 12, up to 16 weeks
Change in Biomarkers in Exercise Group - Meso scale
Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At baseline and week 12, up to 16 weeks
Change in Biomarkers in Exercise Group - Mass cytometry
Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments.
Time frame: At baseline and week 12, up to 16 weeks
Change in Biomarkers in Control Group - Meso Scale
Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. Additionally, Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments.
Time frame: At baseline and week 12, up to 16 weeks
Change in Biomarkers in Control Group - Mass cytometry
Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments.
Time frame: At baseline and week 12, up to 16 weeks
Change in Participant Weight in Exercise Group
Defined as the percent change in weight for Exercise Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
Change in Participant Weight in Control Group
Defined as the percent change in weight for Control Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
Change in Cardiorespiratory Fitness in Exercise Group
Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
Change in Cardiorespiratory Fitness in Control Group
Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
10-Repetition Max Test in Exercise Group
The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
10-Repetition Max Test in Control Group
The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing.
Time frame: At baseline and week 12, up to 16 weeks
Change in Minutes of Total Exercise for Exercise Group
Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests.
Time frame: Up to 16 weeks
Change in Minutes of Total Exercise for Control Group
Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests.
Time frame: Up to 16 weeks