Exercise Treatment for Breast Cancer

Not currently recruiting at 13 trial locations

Overseen By Lee Jones, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Endocrine therapy

Disqualifiers: Life expectancy <6 months, others

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

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how aerobic exercise might benefit individuals with metastatic breast cancer. Researchers aim to determine if exercising during regular hormone therapy can slow tumor growth and delay treatment resistance. Participants will engage in supervised walking sessions each week, ranging from 90 to 375 minutes, for six months. This trial targets postmenopausal women with metastatic breast cancer who are currently inactive (less than 60 minutes of exercise per week) and are already on their first hormone treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that you should be receiving first-line endocrine-based therapy, so you may need to continue with those treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise is generally safe for people with breast cancer. In some studies, patients found aerobic exercise manageable, and it even improved their heart and lung health. However, for some patients, especially those with metastatic cancer, maintaining an exercise routine proved challenging.

Most studies did not identify serious side effects, and when unwanted effects were assessed, they were uncommon. This indicates that while aerobic exercise is mostly safe, individual experiences can vary. Consulting a doctor about any exercise plans is always advisable, especially during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the exercise treatment for breast cancer because it offers a non-invasive alternative that could enhance recovery and quality of life. Unlike traditional treatments like surgery, chemotherapy, and radiation, which can have significant side effects, this approach uses tailored aerobic exercise to potentially mitigate fatigue and improve overall health. The treatment is remotely supervised and adapted to individual needs through TeleEx technology, making it flexible and accessible for patients. By continuously adjusting exercise intensity, it aims to maximize benefits and ensure sustainability throughout the recovery process.

What evidence suggests that this trial's exercise treatments could be effective for metastatic breast cancer?

Research has shown that aerobic exercise can benefit people with breast cancer. Studies have found that it improves quality of life and reduces fatigue. Exercise also lowers the risk of cancer recurrence and reduces mortality rates among breast cancer patients. For those with hormone receptor-positive (HR+) tumors, exercise may help shrink the tumor. This trial will evaluate different durations of aerobic training, ranging from 90 to 375 minutes per week, to determine their effects on breast cancer outcomes. These findings suggest that aerobic exercise might support traditional treatments by possibly delaying resistance to hormone therapy and slowing tumor growth. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer who are sedentary and starting first-line endocrine therapy. They must be cleared for exercise, willing to follow study procedures, have a BMI of at least 18.5, and can't be in other exercise or weight loss programs or have a life expectancy under six months.

Inclusion Criteria

My breast cancer is HR-positive and HER2-negative.

You do not exercise regularly, meaning you do less than 60 minutes of exercise per week.

My brain lesions have been treated and stable for 2 months or more.

Exclusion Criteria

You are currently taking part in a weight loss or exercise program.

You have trouble understanding or following instructions.

You are not expected to live for more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aerobic exercise treatment alongside standard hormone therapy for metastatic breast cancer

24 weeks

Up to 7 sessions per week (remote supervision)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Treatment

Trial Overview The study is examining the effects of aerobic exercise alongside standard first-line treatment for metastatic breast cancer. The goal is to see if exercise can help delay resistance to hormone therapy and slow tumor growth.

How Is the Trial Designed?

Group I: aerobic training 90 mins/wk Experimental Treatment 1 Intervention

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Group II: aerobic training 375 mins/week Experimental Treatment 1 Intervention

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Group III: aerobic training 300 mins/week Experimental Treatment 1 Intervention

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Group IV: aerobic training 225 mins/wk Experimental Treatment 1 Intervention

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Group V: aerobic training 150 mins/wk Experimental Treatment 1 Intervention

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

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]

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 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 supervised exercise program for breast cancer survivors showed significant improvements in motivational factors related to exercise, particularly in autonomy, with a notable increase in the immediate exercise group compared to the delayed group.

The study involved 60 participants and achieved a 61.3% adherence rate, suggesting that early engagement in exercise can foster a positive attitude towards physical activity, potentially leading to better long-term adherence post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. Milne, HM., Wallman, KE., Gordon, S., et al.[2018]

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]

A case study of a breast cancer patient who underwent two mastectomies and subsequent treatments showed that a 6-month exercise intervention significantly improved her muscular strength and cardiovascular function.

The exercise program also helped reduce cancer-related fatigue and depression, highlighting the importance of collaborative health efforts to enhance the quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study: prescriptive exercise intervention after bilateral mastectomies. Carter, SD., Drum, SN., Hayward, R., et al.[2004]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[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]

In a 12-week supervised exercise program involving 141 overweight or obese breast cancer patients, adherence to national physical activity guidelines increased significantly from 38.3% at baseline to 44.7% after 26 weeks, indicating that exercise can help maintain physical activity during adjuvant endocrine therapy.

The study also found significant improvements in metabolic syndrome, body composition, health-related quality of life, and breast cancer-specific symptoms, suggesting that supervised exercise not only enhances physical activity but also contributes to overall health and well-being in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised exercise during adjuvant endocrine therapy in overweight or obese patients with breast cancer: The I-MOVE study. Ormel, HL., Schröder, CP., van der Schoot, GGF., et al.[2021]

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]

A 16-week moderate-intensity exercise program for women with metastatic breast cancer did not show significant improvements in physical functioning or weekly exercise minutes compared to a control group, indicating that exercise may not be as beneficial for this population as it is for those with early-stage breast cancer.

Despite the lack of significant results, the study highlights the need for further research to explore alternative interventions that could help women with metastatic breast cancer manage symptoms and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a physical activity intervention in women with metastatic breast cancer. Ligibel, JA., Giobbie-Hurder, A., Shockro, L., et al.[2016]

Citations

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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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7063018/

Benefits of Aerobic Exercise for Breast Cancer Survivors Studies reported that aerobic exercise can significantly improve the quality of life in BC survivors. Moreover, aerobic exercise alleviated the symptoms of ...

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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.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2006.08.2024

Effects of Aerobic and Resistance Exercise in Breast ... Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2095254625000432

Effects of aerobic or resistance exercise during ... Among patients with HR+ tumors, the exercise interventions showed beneficial effects on change in tumor size, pathologic complete response, and axillary lymph ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29624641/

Feasibility, safety, and efficacy of aerobic training in pretreated ... Aerobic training at the dose and schedule tested is safe but not feasible for a significant proportion of patients with metastatic breast cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228135/

Effects of Aerobic Exercise on Cardiorespiratory Fitness and ... Aerobic exercise is well tolerated and improves CRF in long-term anthracycline-treated BCS more than a decade after treatment. However, the ...

8. tandfonline.com tandfonline.com/doi/full/10.3109/0284186X.2013.781673

Safety and efficacy of aerobic training in operable breast ... The current evidence suggests that aerobic training is safe during primary adjuvant therapy. However, only 14% of studies reported monitoring adverse events ( ...

9. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20592-9

Effectiveness of aerobic exercise intervention on ... Our study indicates that AE has a positive effect in reducing cardiovascular risk factors. The individualization principle of AE deserves more attention in the ...

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

Supervised, structured and individualized exercise in ... Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: a randomized controlled trial.