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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two different group exercise programs can help women build muscle after breast cancer treatment. One group will follow a workout plan designed by strength coaches, while the other will use a plan from the American College of Sports Medicine. Women who have completed breast cancer treatments such as surgery or radiation, but are not currently undergoing chemotherapy, may be suitable candidates. The goal is to determine which exercise plan is most effective for increasing muscle mass. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance post-treatment recovery options for future patients.

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 prior data suggests that these exercise regimens are safe for breast cancer survivors?

Research shows that exercise programs can be safe for women who have undergone breast cancer treatment. Studies have found that a specific exercise plan, including high-intensity strength training, is well-tolerated. Participants in these studies adhered to the program without major problems.

Another study found that these exercise routines did not increase the risk of lymphedema, a common concern for breast cancer survivors. This suggests that the exercise plan is safe for most individuals.

Overall, the exercise program used in this trial proved to be safe and feasible, with participants completing it without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EXERT-BCH Exercise Regimen because it explores a tailored exercise approach specifically designed to maximize muscle growth, known as hypertrophy, in breast cancer patients. Unlike standard exercise guidelines from the American College of Sports Medicine, which provide a general framework for resistance training, this regimen is crafted using strategies from strength and conditioning coaches, potentially offering more personalized and effective outcomes. This trial could uncover new insights into optimizing exercise for cancer recovery, potentially leading to improved quality of life and physical health for participants.

What evidence suggests that this trial's exercise regimens could be effective for increasing muscle mass in breast cancer survivors?

Research shows that exercise programs like the EXERT-BCH offer promising benefits for women treated for breast cancer. In this trial, participants in the experimental arm will follow a regimen commonly used by strength and conditioning coaches, as part of the standard regimens at the Exercise Oncology Center (EOC). Meanwhile, the control arm will adhere to resistance training guidelines from the American College of Sports Medicine (ACSM). Studies have found that these exercise routines can improve muscle strength and size, which is crucial for recovery after cancer treatment. Participants in past studies reported feeling less tired, experiencing a better quality of life, and having fewer symptoms of depression over time. Most participants maintained the exercise program, demonstrating its manageability and effectiveness. These benefits suggest that a structured exercise plan can be vital for recovery and long-term health for breast cancer survivors. ^{1 2 3 4 5}

Who Is on the Research Team?

Colin Champ, MD, CSCS

Principal Investigator

Radiation Oncologist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10943368/

EXERT‐BC: A pilot study of an exercise regimen designed ... The EXERT‐BC trial assesses the safety and feasibility of an evidence‐based, dose‐escalated resistance training regimen among BC survivors.

2. ascopubs.org ascopubs.org/doi/10.1200/OP.2023.19.11_suppl.494

EXERT-BC: A prospective study of an exercise regimen ... EXERT-BC: A prospective study of an exercise regimen designed to improve functional mobility, body composition, and strength after treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06115486

EXERT-BCH Exercise Regimen to Improve Muscle Mass ... 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38491821/

EXERT-BC: A pilot study of an exercise regimen designed ... Session attendance exceeded a prespecified threshold of 75%, and 98% patients reported ongoing compliance to an exercise regimen following regimen completion.

5. withpower.com withpower.com/trial/phase-breast-neoplasms-10-2023-4e026

Exercise Regimen for Breast Cancer Participants experienced reduced fatigue, improved quality of life, and fewer depressive symptoms at 24 weeks compared to both baseline and 12 weeks, indicating ...