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

50 Participants Needed

Trial Summary

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 data supports the idea that Exercise Program for Breast Cancer is an effective treatment?

The available research shows that exercise programs, including aerobic and resistance training, can improve the quality of life for breast cancer patients and survivors. Studies indicate that these exercise programs help reduce fatigue, enhance physical performance, and improve overall well-being during and after treatment. For example, one study found that a 12-week exercise program increased muscular strength and improved quality of life in breast cancer survivors. Another study highlighted that exercise during chemotherapy helped maintain physical functioning and psychosocial health. These findings suggest that exercise is a beneficial treatment for managing the side effects of breast cancer. ^{1 2 3 4 5}

What safety data exists for exercise programs in breast cancer treatment?

Exercise programs, including aerobic and resistance training, have been shown to be safe for breast cancer survivors. Studies indicate that physical activity can be performed safely during and after treatment, with benefits such as improved fitness, strength, and quality of life. Although more research is needed, the American Cancer Society and American College of Sports Medicine recommend regular moderate-intensity exercise for most breast cancer survivors. ^{5 6 7 8 9}

Is the Exercise Intervention a promising treatment for breast cancer?

Yes, the Exercise Intervention is a promising treatment for breast cancer. It can improve physical and mental health, boost energy, and enhance quality of life for breast cancer survivors. Exercise programs can be enjoyable and social, helping patients feel better during and after treatment. ^{7 10 11 12 13}

What is the purpose of this trial?

This clinical trial evaluates the impact of a tailored physical activity program on physical activity in patients with breast cancer that has spread from where it first started to other places in the body (metastatic). It has been shown that decreased physical activity contributes to poor performance and quality of life. Evidence has also shown that exercise could improve physical fitness, physical functioning, quality of life, and cancer-related fatigue, however, there is concern that it may not be available to those with physical limitations. The proposed physical activity program offers a comprehensive and individualized assessment for each metastatic breast cancer patient and includes a high quality, tailored exercise home-based program designed by an advanced qualified cancer exercise specialist. A tailored physical activity program may improve physical activity in metastatic breast cancer patients.

Eligibility Criteria

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

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)?'

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

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

Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. [2022]

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

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. [2022]

4. Germany 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. [2019]

5. United States 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. [2023]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

10. England pubmed.ncbi.nlm.nih.gov

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

11. England 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. [2021]

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

Maximizing exercise in breast cancer survivors. [2009]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of concurrent aerobic and strength training on breast cancer survivors: a pilot study. [2018]