Exercise Program for Breast Cancer

Overseen By Erin kelly, DO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Severe cardiopulmonary, Metabolic, Renal, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a personalized exercise program can improve physical activity and quality of life for women with metastatic breast cancer (cancer that has spread to other parts of the body). The program includes virtual exercise sessions designed by a cancer exercise specialist, focusing on enhancing physical fitness and reducing cancer-related fatigue. Women who may be suitable for the trial have received a diagnosis of metastatic breast cancer within the last five years and currently engage in less than the recommended amount of weekly exercise. Participants need access to a smart device with Wi-Fi for virtual sessions. As an unphased trial, this study offers a unique opportunity to enhance well-being through a tailored exercise program.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this exercise program is safe for metastatic breast cancer patients?

Research shows that exercise programs are generally safe for breast cancer patients, even for those with metastatic cancer. Studies have found that structured and supervised exercise can enhance quality of life and reduce fatigue without causing harm. For instance, one study found that exercise helped reduce pain and improve breathing. Another study showed that strength training did not worsen lymphedema (swelling often caused by breast cancer treatment) and actually helped reduce fluid levels in patients. These findings suggest that exercise can be a safe and beneficial option for many patients, even those with advanced cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "2Unstoppable Strong" exercise program because it offers a supportive and flexible approach to managing breast cancer. Unlike traditional treatments such as surgery, chemotherapy, and radiation, which directly target cancerous cells, this program focuses on improving patients' overall well-being through virtual exercise sessions. The unique feature of this intervention is its accessibility and personalization, as participants receive live and recorded classes tailored to their health needs via Zoom or FaceTime. This innovative method aims to enhance recovery, boost physical health, and improve quality of life, all from the comfort of the participant's home.

What evidence suggests that this exercise program is effective for metastatic breast cancer?

Research has shown that exercise can greatly improve quality of life, reduce fatigue, and enhance physical abilities in breast cancer patients. Studies have found that physical activity can lower the risk of cancer recurrence and may even decrease mortality rates. Strength training, in particular, increases muscle mass in these patients. Additionally, combining exercise with self-care techniques has demonstrated even greater benefits for boosting activity levels and quality of life. In this trial, participants will engage in the 2Unstoppable Strong program, a personalized exercise plan that could be very helpful for those living with metastatic breast cancer. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic breast cancer who are looking to improve their physical activity and quality of life. The program is tailored, considering individual limitations, and designed by a specialist to be done at home.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

Insufficiently inactive defined as answering 'no' to screening question 'On average, do you engage in at least 75 minutes a week of vigorous activity (like jogging) or at least 150 minutes a week of moderate activity (like a brisk walk)?'

Receiving treatment at the Sidney Kimmel Caner Center (SKCC) in Center City, New Jersey, Northeast, Abington or Methodist Hospital

Exclusion Criteria

Any condition that may limit the ability to comply with behavioral and physical recommendations of the virtual exercise program

Pregnancy

I need help or a device to walk safely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Assessment

Participants undergo a 30-minute assessment with the instructor to review health history, concerns, and limitations

1 week

1 visit (virtual)

Treatment

Participants engage in a 6-week tailored physical activity program with weekly live virtual exercise sessions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in physical activity, physical function, and quality of life

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The study tests a personalized home-based exercise program developed by cancer exercise specialists. It aims to see if this intervention can boost physical fitness, functioning, quality of life, and reduce fatigue in metastatic breast cancer patients.

How Is the Trial Designed?

Group I: Supportive care (virtual exercise sessions) Experimental Treatment 5 Interventions

The 2Unstoppable Strong program is 6 weeks with a weekly live via Zoom but also recorded exercise class. All participants will complete a phone screening (with 2Unstoppable) to determine eligibility and interest; a 30-minute assessment with the instructor over Zoom or FaceTime to review health history, concerns, \& limitations; then provide a signed Physician Release, a signed liability waiver and a completed health questionnaire.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

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]

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]

In a pilot trial involving 10 breast cancer patients undergoing neoadjuvant chemotherapy, adding a supervised exercise program resulted in a significant decrease in body mass index (BMI) compared to those receiving chemotherapy alone (28.0 vs. 35.8, P = 0.03).

While the exercise group showed a trend towards lower Ki-67 levels (7% vs. 29%, P = 0.14), indicating potential benefits in tumor proliferation rates, the difference was not statistically significant, suggesting further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. Rao, R., Cruz, V., Peng, Y., et al.[2021]

Exercise significantly improves quality of life for women with breast cancer, as shown by positive outcomes in 14 randomized controlled trials, despite some variability in results.

In addition to enhancing quality of life, exercise also boosts physical functioning and cardiorespiratory fitness while reducing fatigue symptoms in breast cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. McNeely, ML., Campbell, KL., Rowe, BH., et al.[2022]

A systematic review of 28 randomized controlled trials found that various exercise programs, particularly resistance training combined with cardiovascular endurance training, significantly improve physical performance and reduce perceived fatigue in breast cancer patients undergoing initial treatment.

Quality of life improvements were less pronounced compared to physical performance and fatigue, indicating that while exercise is beneficial, it may not greatly enhance overall quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of training interventions on physical performance, quality of life, and fatigue in patients receiving breast cancer treatment: a systematic review. Gebruers, N., Camberlin, M., Theunissen, F., et al.[2019]

A 12-week supervised resistance exercise program combined with home-based aerobic exercise is being tested on 60 female breast cancer survivors to see if it improves muscular strength and health-related quality of life compared to aerobic exercise alone.

The study aims to provide clear and standardized reporting of the exercise intervention, which could help improve future exercise prescriptions for breast cancer survivors dealing with treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial. Soriano-Maldonado, A., Carrera-Ruiz, Á., Díez-Fernández, DM., et al.[2023]

In a study involving 242 breast cancer patients undergoing chemotherapy, both aerobic and resistance exercises improved self-esteem, physical fitness, and body composition without causing lymphedema or significant adverse events.

Resistance exercise was particularly effective in enhancing muscular strength and lean body mass, and it also increased the chemotherapy completion rate, indicating its potential benefits during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. Courneya, KS., Segal, RJ., Mackey, JR., et al.[2022]

A meta-analysis of 11 randomized controlled trials involving 666 breast cancer patients found that physical exercise significantly improves cardiovascular health by lowering systolic and diastolic blood pressure, triglyceride levels, and body mass index.

Exercise also enhances cardiovascular fitness by increasing peak oxygen uptake and high-density lipoprotein cholesterol levels, suggesting it could be an effective intervention for cardiovascular care in breast cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical exercise on the cardiovascular system in breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. Wang, S., Yang, T., Qiang, W., et al.[2021]

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]

Regular moderate exercise significantly enhances physical, mental, and social well-being in breast cancer survivors after treatment, promoting overall recovery and quality of life.

A supportive environment and positive mindset towards exercise are crucial for encouraging breast cancer survivors to adopt and maintain an active lifestyle, which can improve their physical strength and endurance post-therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing exercise in breast cancer survivors. Adkins, BW.[2009]

A 24-week combined aerobic and strength training program significantly improved physiological parameters in female breast cancer survivors, including a 38.8% increase in VO2max and a reduction in fat mass by 6.3%.

The program also enhanced psychological well-being, as indicated by significant increases in quality of life scores, demonstrating the importance of structured physical activity in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of concurrent aerobic and strength training on breast cancer survivors: a pilot study. De Luca, V., Minganti, C., Borrione, P., et al.[2018]

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]

Women with a history of breast cancer who engage in physical activity have a 30% to 50% lower risk of breast cancer recurrence and overall mortality compared to those who are sedentary, based on observational studies.

Small intervention studies indicate that exercise is safe during and after breast cancer treatment, leading to improvements in fitness, strength, and quality of life, prompting organizations like the American Cancer Society to recommend regular moderate-intensity activity for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of adjuvant and posttreatment exercise programs in breast health. Ligibel, JA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11184867/

Effectiveness of exercise modalities on breast cancer ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

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. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35043

What are the most effective exercise, physical activity and ... Resistance exercise was the most effective intervention to increase lean mass (0.7 kg; 95% CI, 0.5–1.0 kg) in breast cancer patients.

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

Effect of physical exercise on the quality of life of women ... Women surviving breast cancer (WSBC) may experience reduced quality of life (QoL) due to disease-associated manifestations and undergone treatment. Engagement ...

5. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... The results of this RCT study suggest that combined exercise and SM has increased benefits for physical activity level, quality of life, health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9873715/

Long-term effects of exercise interventions on physical ... The physical activity behaviour in breast cancer patients remained improved for several months beyond the end of exercise interventions, but effects were small.

7. nature.com nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ... Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835176

Resistance Training and Lymphedema in Breast Cancer ... In this cohort study of breast cancer survivors, intense resistance training did not exacerbate lymphedema and was associated with improvements in fluid ...