Exercise Regimen for Breast Cancer

Overseen By Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Severe arthritis, Joint conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 38

30 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on active chemotherapy to participate.

What data supports the effectiveness of the treatment EXERT-BCH Exercise Regimen for breast cancer survivors?

Research shows that exercise can significantly benefit breast cancer survivors by improving their physical and psychological health. Regular moderate-intensity exercise, combined with resistance training, can enhance aerobic capacity and quality of life, making it an effective part of recovery and ongoing health management. ^{1 2 3 4 5}

Is the exercise regimen for breast cancer survivors safe?

Exercise programs, including aerobic and resistance training, have been shown to be safe for breast cancer survivors, with no increased risk of lymphedema (swelling due to lymph fluid). These programs can improve muscle strength and overall health without significant adverse effects. ^{1 3 6 7 8}

How is the EXERT-BCH Exercise Regimen treatment different from other treatments for breast cancer survivors?

The EXERT-BCH Exercise Regimen is unique because it focuses on a structured exercise program specifically designed for breast cancer survivors, incorporating both aerobic and resistance training to improve physical and psychological health. Unlike standard treatments, it emphasizes enjoyable activities, skill development, and social interaction, which are not typically part of conventional cancer care. ^{1 2 6 8 9}

What is the purpose of this trial?

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

Research Team

Colin Champ, MD, CSCS

Principal Investigator

Radiation Oncologist

Eligibility Criteria

This trial is for women aged 20-89 who have been treated for breast cancer, including ductal carcinoma in situ or invasive carcinoma. They must have completed certain treatments like surgery, radiation, chemotherapy, hormonal therapy but can't be on active chemotherapy.

Inclusion Criteria

I have had breast cancer treatment but am not currently on chemotherapy.

You are aged between 20 and 89 years, have a biopsy-confirmed diagnosis of either ductal carcinoma in situ or an invasive type of breast cancer, and you have already received treatment such as surgery, radiation therapy, chemotherapy, immunotherapy or hormonal therapy

I am between 20 and 89 years old.

Exclusion Criteria

My doctor thinks it's unsafe for me to do resistance training due to my severe joint or heart condition.

I am currently receiving chemotherapy for breast cancer.

I cannot safely do group exercise as decided by the study leader.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Fitness Evaluation

Participants undergo a fitness evaluation to customize the exercise program

1 week

1 visit (in-person)

Exercise Program

Participants engage in a monitored group exercise regimen to improve muscle mass

12 weeks

Approximately 36 visits (in-person)

Follow-up

Participants are monitored for changes in muscle and fat mass after the exercise program

4 weeks

Treatment Details

Interventions

• EXERT-BCH Exercise Regimen

Trial Overview The study compares two exercise regimens to increase muscle mass after breast cancer treatment. One follows the American College of Sports Medicine guidelines and the other varies repetitions per set (6-12-25).

Participant Groups

Group I: Experimental Arm / EOC Guidelines Experimental Treatment 1 Intervention

The experimental group will use a regimen that is often used by strength and conditioning coaches to maximize hypertrophy, and is part of the standard regimens at the Exercise Oncology Center (EOC)

Group II: Control Arm / ACSM Guidelines Experimental Treatment 1 Intervention

The control group will follow resistance training guidelines from the American College of Sports Medicine (ACSM) with the goal of promoting hypertrophy

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Findings from Research

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 community-based exercise program over 16 weeks significantly improved aerobic capacity (measured as VO2peak) and physical function in breast cancer survivors, with both groups showing notable enhancements in their exercise performance.

Breast cancer survivors improved their peak cycling power more than control participants, indicating that tailored community exercise interventions can effectively support recovery and fitness in this population, although the improvements may not match those seen in controlled laboratory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer. Lee, JT., Wagoner, CW., Sullivan, SA., et al.[2021]

An 8-month exercise intervention for women with newly diagnosed breast cancer significantly improved overall survival, with only 5.3% deaths in the exercise group compared to 11.5% in the usual care group after a median follow-up of 8.3 years.

The exercise program also showed a trend towards better disease-free survival, particularly benefiting younger women and those with more advanced disease, suggesting that tailored exercise interventions can enhance outcomes for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise following breast cancer: exploratory survival analyses of two randomised, controlled trials. Hayes, SC., Steele, ML., Spence, RR., et al.[2018]

The BEAUTY program, a community exercise initiative for breast cancer survivors, showed significant improvements in physical fitness and psychosocial outcomes after 24 weeks, including better waist-to-hip ratio, treadmill performance, and VO2max.

Participants experienced reduced fatigue, improved quality of life, and fewer depressive symptoms at 24 weeks compared to both baseline and 12 weeks, indicating that longer exercise durations may be more beneficial for recovery during and after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. Leach, HJ., Danyluk, JM., Nishimura, KC., et al.[2018]

A systematic review of nine randomized controlled trials found that aerobic exercise, often combined with resistance training, significantly improves the quality of life for breast cancer patients and survivors.

The most effective exercise programs typically involved three sessions per week at a moderate intensity (50% to 80% of maximum heart rate) for over 30 minutes, all supervised by a physiotherapist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. Pastakia, K., Kumar, S.[2022]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

A 20-week supervised resistance training and support program for African-American breast cancer survivors showed that it is feasible to conduct lifestyle interventions in a community setting, with 19 out of 27 participants actively engaging in the program.

Participants who attended at least 70% of the exercise sessions experienced significant reductions in waist circumference and body fat percentage, along with a notable decrease in circulating C-peptide levels, indicating potential improvements in cancer-related biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Based Exercise and Support Group Program in African-American Breast Cancer Survivors (ABCs). Nock, NL., Owusu, C., Kullman, EL., et al.[2021]

Resistance training (RT) is safe for breast cancer survivors (BCS) and does not increase the risk of lymphedema, based on an analysis of ten studies published between 2000 and 2016.

RT effectively improves muscle strength in BCS, particularly when using high loads, although changes in body mass composition were minimal, indicating the need for careful manipulation of training variables for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Effects of Resistance Training in Breast Cancer Survivors. Dos Santos, WDN., Gentil, P., de Moraes, RF., et al.[2018]

A study involving 27 breast cancer survivors over 6 months showed that resistance exercise training did not significantly change arm circumferences, indicating no increased risk of lymphedema.

No adverse lymphedema-related events were reported, suggesting that resistance exercise can be a safe and beneficial activity for women at risk of breast cancer-related lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of resistance exercise in women with or at risk for breast cancer-related lymphedema. Simonavice, E., Kim, JS., Panton, L.[2018]

References

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

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

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

Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise following breast cancer: exploratory survival analyses of two randomised, controlled trials. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. [2018]

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

Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. [2022]

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

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

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

A Community-Based Exercise and Support Group Program in African-American Breast Cancer Survivors (ABCs). [2021]

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

Chronic Effects of Resistance Training in Breast Cancer Survivors. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Effects of resistance exercise in women with or at risk for breast cancer-related lymphedema. [2018]