Exercise Treatment for Breast Cancer

Recruiting at 12 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

54 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. However, it mentions that you should be receiving first-line endocrine-based therapy, so you may need to continue with those treatments.

What data supports the effectiveness of the treatment Exercise Treatment for breast cancer?

Research shows that exercise can improve quality of life and reduce fatigue in breast cancer patients. It may also help in reducing tumor size and improving survival rates when combined with chemotherapy. ^{1 2 3 4 5}

Is exercise treatment safe for breast cancer patients?

Research shows that exercise is generally safe for breast cancer patients, both during and after treatment. Studies have found that physical activity can improve fitness, strength, and quality of life without significant safety concerns. ^{6 7 8 9 10}

How does exercise treatment differ from other treatments for breast cancer?

Exercise treatment for breast cancer is unique because it focuses on improving physical fitness, quality of life, and potentially survival through moderate-intensity activities and resistance training, rather than using drugs or surgery. It also emphasizes psychological benefits by incorporating enjoyable and social activities, which can help manage fatigue and depression. ^{2 11 12 13 14}

What is the purpose of this trial?

This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.

Research Team

Neil Iyengar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

4. England 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. [2023]

6. Netherlands 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. [2021]

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

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

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

Risks and benefits of physical activity among breast cancer survivors who have completed treatment. [2016]

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

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

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

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

11. England pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Physical activity and breast cancer survival. [2023]

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

A case study: prescriptive exercise intervention after bilateral mastectomies. [2004]

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

Randomized trial of a physical activity intervention in women with metastatic breast cancer. [2016]