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Trial Title:
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
NCT ID:
NCT06322888
Condition:
Breast Cancer
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Training Program
Description:
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.
Arm group label:
Arm A: Exercise Intervention
Summary:
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
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 18-59
- Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram
within the past 12 months
- Physically inactive; engaging in <60 minutes of moderate or vigorous intensity
exercise per week, as assessed by Godin Leisure Time screener
- Not pregnant or breastfeeding
- English speaking and able to read English. Investigators are only enrolling
English-speaking participants to this study at this time due to the fact that
investigators currently only have English-speaking exercise trainers with the proper
qualifications to conduct the exercise training
- Written informed consent prior to any study-related procedures
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 or implantable hormonal contraceptives, postmenopausal hormone replacement
therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena
or other IUD is acceptable
- Consistent strength training in the past 3 months
- Use of weightloss drugs
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that
preclude moderate exercise. 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)
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
59 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Ligibel, MD
Phone:
617-632-3800
Email:
Jennifer_Ligibel@dfci.harvard.edu
Investigator:
Last name:
Jennifer Ligibel, MD
Email:
Principal Investigator
Start date:
March 28, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Breast Cancer Research Foundation
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322888
