Exercise Training for Breast Cancer

Overseen By Eileen Handberg

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: CDK4/6 inhibitors, PARP inhibitors

Disqualifiers: Radiation therapy, Lymphedema, Cardiovascular diseases, others

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

Compensation: Varies

Number of Visits: Unknown

68 Participants Needed

Trial Summary

What is the purpose of this trial?

Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving targeted therapies like CDK4/6 or PARP inhibitors, you cannot participate in this trial.

What data supports the effectiveness of the treatment Exercise training for Breast Cancer?

Research shows that exercise training can help breast cancer patients by reducing side effects of treatment and improving quality of life. Studies have found that both endurance and resistance training during chemotherapy can lead to better outcomes compared to standard care. ^{1 2 3 4 5}

Is exercise training safe for breast cancer patients?

Exercise training, including aerobic and resistance exercises, is generally safe for breast cancer patients and can help manage side effects like fatigue and loss of muscle strength. However, it is important to have guidance from healthcare professionals to ensure exercises are done safely, especially for those with conditions like lymphedema. ^{2 6 7 8 9}

How is exercise training different from other treatments for breast cancer?

Exercise training is unique because it not only helps reduce the risk of breast cancer but also significantly improves the quality of life for survivors by reducing fatigue and enhancing physical and immune function. Unlike other treatments, it combines strength and aerobic exercises to maximize benefits and is part of a comprehensive rehabilitation program that can be tailored to individual needs. ^{2 9 10 11 12}

Research Team

Demetra Christou, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for women aged 18-85 with primary invasive non-metastatic breast cancer (stages I-III) who are about to start chemotherapy. Participants must be able to exercise, give consent, and not have severe lymphedema or cardiovascular diseases. It's not for those already doing a lot of aerobic exercise or involved in other experimental studies.

Inclusion Criteria

You don't have any reasons that make exercise unsafe for you.

I have been diagnosed with early-stage (I-III) breast cancer that has not spread.

I am about to start specific chemotherapy before or after surgery.

Exclusion Criteria

You are currently doing a lot of moderate-intensity aerobic exercise each week.

I have a history of significant heart problems.

I am currently on medication specifically for cancer (like CDK4/6 or PARP inhibitors).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Exercise Intervention

Participants undergo chemotherapy while participating in an exercise intervention to evaluate cardiovascular function

12 weeks

Regular visits for exercise sessions and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exercise training

Trial Overview The study tests whether a special exercise program can protect the heart and blood vessels from damage during chemotherapy for breast cancer patients. The goal is to see if this can prevent future heart disease in these individuals.

Participant Groups

Group I: All-extremity exercise Experimental Treatment 1 Intervention

Group II: Treadmill exercise Active Control 1 Intervention

Group III: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The Strength after Breast Cancer (SABC) program was successfully implemented in outpatient rehabilitation clinics, with 76% of surveyed clinicians adopting it and 93% continuing to deliver the program, indicating strong sustainability.

The program reached an average of 13 patients per clinic, primarily through referrals from oncology clinics, although barriers such as lack of referrals and competing clinic demands were noted, highlighting areas for improvement in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. Calo, WA., Doerksen, SE., Spanos, K., et al.[2022]

In a study of 242 breast cancer patients undergoing chemotherapy, those who preferred resistance exercise training (RET) showed significant improvements in quality of life (QoL) when assigned to RET compared to usual care or aerobic exercise training, highlighting the importance of patient preference in exercise interventions.

Demographic and clinical factors, such as marital status, age, chemotherapy regimen, and disease stage, influenced the effectiveness of exercise training, with unmarried, younger patients on nontaxane therapies experiencing better outcomes in terms of strength, lean body mass, and fat loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of the effects of exercise training in breast cancer patients receiving chemotherapy: a randomized controlled trial. Courneya, KS., McKenzie, DC., Mackey, JR., et al.[2008]

In a study of 67 breast cancer patients undergoing chemotherapy, both endurance training (ET) and resistance training (RT) significantly improved muscular strength compared to standard care, highlighting the efficacy of exercise during treatment.

Quality of life (QoL) improved significantly in the RT group, while the standard care group experienced a decrease in QoL, suggesting that incorporating exercise into treatment plans can enhance overall well-being for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Endurance and Resistance Training with Standard Care during Chemotherapy for Patients with Primary Breast Cancer. Schmidt, T., Weisser, B., Dürkop, J., et al.[2019]

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]

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]

Engaging in at least 3 hours of aerobic exercise per week can significantly improve health outcomes for breast cancer survivors, potentially reducing mortality and morbidity rates.

To help survivors adhere to this exercise regimen, a supportive infrastructure is needed to address common side effects of cancer treatment, such as fatigue and joint pain, and to integrate exercise into their ongoing clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for secondary prevention of breast cancer: moving from evidence to changing clinical practice. Schmitz, KH.[2022]

Resistance training (RT) is a safe and feasible exercise intervention for breast cancer patients, showing positive effects on muscle strength, cancer-related fatigue (CRF), and quality of life (QoL) based on a review of randomized controlled trials from the past decade.

Despite the growing evidence supporting RT, there is a lack of standardized guidelines due to the variety of training protocols and methodologies used in studies, indicating a need for more focused research on RT-only interventions across different treatment stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise for Breast Cancer Patients? Evidence from the Last Decade. Gerland, L., Baumann, FT., Niels, T.[2022]

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]

A three-month multidisciplinary rehabilitation program, including physical training and psycho-educational sessions, significantly improved flexibility, walking distance, and overall functional capacity in 103 women after breast cancer treatment, compared to a control group of 106 women who showed no such improvements.

Participants in the experimental group also experienced a decrease in body fat percentage and enhancements in quality of life, emotional state, and various functional roles, highlighting the program's effectiveness in addressing both physical and psychological aspects of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary rehabilitation program after breast cancer: benefits on physical function, anthropometry and quality of life. Leclerc, AF., Foidart-Dessalle, M., Tomasella, M., et al.[2018]

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]

Physical activity is essential for preventing breast cancer and improving the quality of life for patients diagnosed with the disease, as it helps counteract the negative effects of treatment on physical activity levels and well-being.

Comprehensive rehabilitation for breast cancer includes preoperative, perioperative, and postoperative exercise programs, focusing on strength, aerobic training, and shoulder mobility, which have been shown to enhance quality of life and reduce fatigue in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer rehabilitation. Líška, D., Rutkowski, S.[2022]

Women undergoing mastectomy and breast reconstruction for breast cancer often experience musculoskeletal impairments, highlighting the need for targeted physical therapy interventions.

Physical therapists play a crucial role in the recovery process by providing individualized exercise prescriptions, educating patients, and collaborating closely with physicians to address musculoskeletal dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of physical therapy in the rehabilitation of patients with mastectomy and breast reconstruction. McAnaw, MB., Harris, KW.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. [2022]

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

Moderators of the effects of exercise training in breast cancer patients receiving chemotherapy: a randomized controlled trial. [2008]

3. Greece pubmed.ncbi.nlm.nih.gov

Comparing Endurance and Resistance Training with Standard Care during Chemotherapy for Patients with Primary Breast Cancer. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. [2023]

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

Exercise for secondary prevention of breast cancer: moving from evidence to changing clinical practice. [2022]

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

Resistance Exercise for Breast Cancer Patients? Evidence from the Last Decade. [2022]

8. England 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. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Multidisciplinary rehabilitation program after breast cancer: benefits on physical function, anthropometry and quality of life. [2018]

10. Austria pubmed.ncbi.nlm.nih.gov

Exercise in the prevention and rehabilitation of breast cancer. [2021]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

Breast cancer rehabilitation. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The role of physical therapy in the rehabilitation of patients with mastectomy and breast reconstruction. [2019]