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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how exercise might lower the risk of breast cancer for women with dense breast tissue. Participants will either join a 12-week exercise program or be placed on a waitlist for the program. Researchers will track changes in breast tissue and blood to understand the impact of exercise. Women with dense breast tissue, who exercise less than an hour per week, and have no history of breast cancer might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research on exercise and breast cancer risk.

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 prior data suggests that this exercise program is safe for participants?

Research shows that exercise is safe and beneficial for many people, including those with breast cancer. Studies have found that exercise can reduce treatment side effects and enhance quality of life. Regular exercisers often experience fewer negative effects from cancer treatments.

Evidence also suggests that physical activity may lower the risk of cancer recurrence and improve survival rates for breast cancer patients. Regular exercise is associated with better overall health.

While this trial's exercise program focuses on prevention, past research with cancer patients indicates that exercise is generally well-tolerated. No reports of serious safety concerns have emerged, suggesting that joining an exercise program is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise might play a direct role in preventing breast cancer. Unlike traditional treatments that focus on medication or surgery, this approach uses regular physical activity as a potential preventive measure. The trial investigates whether a structured exercise program can influence biological markers related to breast cancer risk, offering a non-invasive, lifestyle-based strategy. If successful, this could lead to a shift in how we think about breast cancer prevention, emphasizing proactive health habits over conventional medical interventions.

What evidence suggests that exercise might be an effective prevention for breast cancer?

Research shows that exercise positively affects breast cancer outcomes. Studies have found that regular physical activity links to lower recurrence rates and reduced mortality in breast cancer patients. Exercise also improves quality of life and reduces side effects from breast cancer and its treatment. One study noted benefits such as improved heart and lung health and overall well-being in postmenopausal survivors who exercised. In this trial, participants in the exercise intervention arm will follow a structured exercise program, which could lower breast cancer risks and improve health outcomes. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Not pregnant or breastfeeding

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5981588/

Physical Activity, Exercise and Breast Cancer It appears that exercise can positively influence certain cancer- and treatment-related side effects, quality of life, recurrence, and survival.

2. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325007152

Effect of physical exercise on the quality of life of women ... Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol, 21 (9) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06771635

Effect of Physical Training Program on the Exercise ... This pilot randomized controlled trial aims to evaluate the effects of a 6-week supervised concurrent training program in breast cancer survivors. The program ...

5. researchprotocols.org researchprotocols.org/2025/1/e63891

Efficacy of a Supervised Exercise Program on Pain ... Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782413/

Impact of physical exercise programs in breast cancer ... Physical exercise reduces the impact of treatment-related adverse events to promote a better quality of life and functional outcomes.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834208

Exercise Communication for Breast Cancer Survivors Exercise communication was associated with favorable outcomes, including increased exercise participation and quality of life among breast cancer survivors.