Exercise Training for Breast Cancer Survivors

Overseen By Demetra Christou, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Cardiovascular diseases, Lymphedema, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, certain breast cancer treatments like endocrine therapy and other specified medications are allowed during the study.

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

Research shows that exercise programs can help breast cancer survivors improve their quality of life and physical function. Studies indicate that regular physical activity, including resistance training, can lead to better strength, reduced fatigue, and overall well-being for survivors. ^{1 2 3 4 5}

Is exercise training safe for breast cancer survivors?

Research shows that exercise, including weightlifting and aerobic activities, is generally safe for breast cancer survivors. Studies have found that physical activity can be performed safely during and after treatment, with benefits like improved fitness and quality of life, and low rates of injury. ^{1 4 6 7 8}

How does exercise training differ from other treatments for breast cancer survivors?

Exercise training is unique because it focuses on improving physical, mental, and social well-being through regular physical activity, rather than using medication or surgery. It involves moderate-intensity aerobic and resistance exercises, which can help reduce fatigue, improve quality of life, and potentially lower the risk of cancer recurrence. ^{1 4 9 10 11}

What is the purpose of this trial?

There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.

Research Team

Demetra Christou, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for female breast cancer survivors, aged 40-80, who've completed chemotherapy for primary invasive non-metastatic breast cancer (stages I-III) 6-18 months prior. They must be cleared by a clinician and not engage in regular intense exercise. Excluded are those with severe obesity, ongoing radiation or surgery plans, recent other treatments or interventions that could affect results, and certain cardiovascular conditions.

Inclusion Criteria

I am biologically female.

My breast cancer is in stages I-III and has not spread to distant parts of the body.

Study clinician approval

Exclusion Criteria

Do not meet inclusion criteria

I finished my cancer treatment, like chemo or surgery, within the last 6 months.

You weigh a lot for your height.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive instruction on using a Concept 2 RowErg and engage in moderate-intensity exercise for 50 minutes, 3 days per week, for 12 weeks

12 weeks

Regular sessions 3 times per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of global longitudinal strain and brachial FMD

4 weeks

Treatment Details

Interventions

• Exercise training

Trial Overview The study tests the impact of a novel exercise program on heart health in breast cancer survivors post-chemotherapy. It aims to reduce cardiovascular disease risks through tailored cardiovascular rehabilitation exercises.

Participant Groups

Group I: Indoor Rowing Experimental Treatment 1 Intervention

Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks.

Group II: Usual Care Active Control 1 Intervention

Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

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]

A study of 446 breast cancer survivors over 5 years found that previous exercise habits and quality of life after treatment were key factors influencing long-term physical activity levels.

Interestingly, patients with higher fatigue levels and better emotional functioning at baseline were more likely to increase their exercise levels, suggesting that targeted physical exercise interventions could benefit those struggling with fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors predicting long-term physical activity of breast cancer survivors. 5-year-follow-up of the BREX exercise intervention study. Kokkonen, K., Kellokumpu-Lehtinen, PL., Kankaanpää, M., et al.[2022]

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]

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]

In a study of 27 breast cancer survivors over six months, resistance training significantly improved objective measures of muscular strength and physical function, indicating its potential benefits for recovery post-treatment.

Despite the improvements in physical strength and function, no changes were observed in subjective measures of quality of life, suggesting that further research is needed to understand the full impact of resistance training on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Resistance Training on Physical Function and Quality of Life in Breast Cancer Survivors. Simonavice, E., Liu, PY., Ilich, JZ., et al.[2020]

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]

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]

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]

Exercise interventions in breast cancer rehabilitation are safe and feasible, significantly improving quality of life and helping manage side effects like fatigue and neuropathy.

There is a need for more comprehensive studies to better document the effects of physical activity on recurrence and mortality rates, as current data shows gaps in evidence and application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise and Breast Cancer - What Is the Evidence for Rehabilitation, Aftercare, and Survival? A Review. Wirtz, P., Baumann, FT.[2020]

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]

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. England pubmed.ncbi.nlm.nih.gov

Factors predicting long-term physical activity of breast cancer survivors. 5-year-follow-up of the BREX exercise intervention study. [2022]

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

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

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Resistance Training on Physical Function and Quality of Life in Breast Cancer Survivors. [2020]

6. 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]

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

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

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

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

9. England pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise and Breast Cancer - What Is the Evidence for Rehabilitation, Aftercare, and Survival? A Review. [2020]

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

Maximizing exercise in breast cancer survivors. [2009]