Exercise for Breast Cancer Prevention

Recruiting at 1 trial location

Overseen By Anna Tanasijevic, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Hormonal contraceptives, Hormone replacement

Disqualifiers: Breast cancer, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 39

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain hormonal therapies or weight loss drugs.

What data supports the effectiveness of the treatment Exercise Training Program, Physical Activity Intervention, Exercise Therapy, Rehabilitation Exercise Program for breast cancer prevention?

Research shows that exercise can improve physical well-being, quality of life, and reduce side effects for breast cancer patients. Exercise programs have been found to enhance fitness, muscle strength, and reduce depression, which are important for recovery and overall health. ^{1 2 3 4 5}

Is exercise safe for breast cancer patients?

Exercise programs for breast cancer patients have been shown to be safe, with studies indicating that they can improve physical well-being, quality of life, and reduce treatment side effects. These programs are designed to be accessible and individualized, ensuring safety and adherence for participants. ^{1 3 4 6 7}

How does the exercise training program differ from other treatments for breast cancer prevention?

The exercise training program is unique because it focuses on physical activity to reduce the risk of breast cancer and improve quality of life, rather than using medication or surgery. It combines both strength and aerobic exercises, which have been shown to significantly lower the risk of breast cancer recurrence and mortality, and improve physical and psychological health. ^{3 4 8 9 10}

What is the purpose of this trial?

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

Research Team

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for women who may have a higher risk of breast cancer due to having dense breast tissue. Participants should be willing to join an exercise program or be placed on a waitlist. Specific eligibility details are not provided, but typically include age range, health status, and no current engagement in similar interventions.

Inclusion Criteria

Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months

I am a woman aged between 18 and 59.

Written informed consent prior to any study-related procedures

Exclusion Criteria

I had breast cancer or DCIS before, but I'm not on hormone therapy and have at least one breast not treated with radiation.

I cannot walk 2 blocks without stopping.

I am using hormonal contraceptives, hormone replacement, or specific breast cancer hormone treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline study visit with assessments, breast biopsy, and blood draw

1 week

1 visit (in-person)

Exercise Program

Participants in the exercise group will engage in a 12-week exercise program, 3 times weekly, with exercise logs and additional blood draw after the first session

12 weeks

36 visits (in-person)

End of Study Assessment

End of study visit with assessments, breast biopsy, and blood draw

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in biomarkers and fitness levels

2 weeks

Treatment Details

Interventions

• Exercise Training Program

Trial Overview The REP-D study is testing whether regular exercise can reduce the risk of developing breast cancer in women with dense breasts. It involves comparing changes in breast tissue and blood between those who participate in an exercise training program and those on a waitlist.

Participant Groups

Group I: Arm A: Exercise Intervention Experimental Treatment 1 Intervention

Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session. * End of study visit with assessments, breast biopsy, and blood draw.

Group II: Arm B: Waitlist Control Active Control 1 Intervention

Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * End of study visit with assessments, breast biopsy, and blood draw. * Participants will be offered a complimentary 12-week exercise program after completing the study.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Findings from Research

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

Exercise has been shown to improve key physical health markers in breast cancer survivors, such as peak oxygen consumption, muscle strength, and cardiovascular health, which are linked to better overall health outcomes.

The review will provide recommendations for exercise interventions tailored to breast cancer survivors, highlighting the importance of physical activity in reducing risks of disability and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. Kirkham, AA., Bland, KA., Sayyari, S., et al.[2018]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

Exercise interventions in breast cancer rehabilitation are safe and feasible, significantly improving quality of life and helping manage side effects like fatigue and neuropathy.

There is a need for more comprehensive studies to better document the effects of physical activity on recurrence and mortality rates, as current data shows gaps in evidence and application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise and Breast Cancer - What Is the Evidence for Rehabilitation, Aftercare, and Survival? A Review. Wirtz, P., Baumann, FT.[2020]

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

Engaging in moderate to vigorous physical activity for 3-5 days a week can reduce the risk of breast cancer by 20-40% and significantly lower the risk of death from breast cancer by 50-53% in survivors.

Breast cancer survivors are encouraged to participate in rehabilitation programs that include both strength and aerobic exercises, as these can improve physical functioning, reduce fatigue, enhance immune function, and boost overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the prevention and rehabilitation of breast cancer. Volaklis, KA., Halle, M., Tokmakidis, SP.[2021]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

A supervised exercise training program (SETP) significantly improved health-related quality of life (HRQoL) and functional capacity in 93 women with early-stage breast cancer undergoing chemotherapy, showing less deterioration in various quality of life domains compared to usual care alone.

Participants in the exercise group experienced notable improvements in physical and cognitive functioning, reduced fatigue, and enhanced strength, indicating that exercise can be an effective complementary therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training Benefits Health-Related Quality of Life and Functional Capacity during Breast Cancer Chemotherapy: An RCT. Antunes, P., Joaquim, A., Sampaio, F., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise and Breast Cancer - What Is the Evidence for Rehabilitation, Aftercare, and Survival? A Review. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

8. Austria pubmed.ncbi.nlm.nih.gov

Exercise in the prevention and rehabilitation of breast cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Exercise Training Benefits Health-Related Quality of Life and Functional Capacity during Breast Cancer Chemotherapy: An RCT. [2023]