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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise training can protect the heart health of breast cancer patients undergoing chemotherapy. Participants will engage in either an all-extremity exercise program or treadmill exercise, while some will continue with their usual care. The goal is to determine if exercise can prevent heart problems associated with treatment. Women with stages I-III breast cancer, who are about to start specific types of chemotherapy and have no exercise restrictions, are suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how exercise might benefit heart health during cancer treatment.

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 prior data suggests that this exercise training is safe for breast cancer patients undergoing chemotherapy?

Research shows that exercise is generally safe for breast cancer patients and offers many health benefits. Studies have found that physical activity can reduce the risk of cancer recurrence and improve survival rates. Exercise also helps lessen side effects and boosts overall well-being for people with cancer.

Evidence suggests that exercises involving all parts of the body are a helpful part of treatment, improving physical health and cancer outcomes. Treadmill exercise, another form of physical activity, is also considered safe and beneficial. Most patients handle both types of exercise well, with rare reports of negative effects.

Overall, exercise is a safe and effective way to support health in breast cancer patients, especially during and after treatments like chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise training for breast cancer because it offers a non-invasive, holistic approach that complements traditional treatments like surgery, chemotherapy, and radiation. Unlike standard medical therapies, the all-extremity exercise and treadmill exercise regimens focus on improving physical fitness and potentially enhancing recovery and overall quality of life. These exercise programs might also help reduce fatigue and improve mental health, making them a promising adjunct to conventional cancer care. By integrating physical activity into treatment plans, researchers hope to uncover additional benefits that could reshape supportive care for breast cancer patients.

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

Research has shown that exercise can greatly improve the health and well-being of breast cancer patients. This trial will compare different exercise approaches. Participants in the "All-extremity exercise" arm will engage in exercises involving multiple body parts, while those in the "Treadmill exercise" arm will focus on treadmill-based activities. Studies have found that exercise enhances quality of life, reduces tiredness, and improves physical abilities. It can also lower the risk of cancer returning and decrease death rates among breast cancer patients. Additionally, exercise helps reduce anxiety and depression, which are common during cancer treatment. Overall, adding exercise to treatment plans offers many benefits for breast cancer survivors. ^{1 4 6 7 8}

Who Is on the Research Team?

Demetra Christou, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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]

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