Respiratory Muscle Training for Breast Cancer

Overseen By ASK RPCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Infection, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Respiratory Muscle Training for breast cancer?

Research shows that inspiratory muscle training (a type of respiratory muscle training) can help improve breathing and reduce breathlessness in patients with lung cancer and other thoracic conditions. This suggests it might also help breast cancer patients by strengthening their breathing muscles and improving their ability to exercise. ^{1 2 3 4 5}

Is respiratory muscle training safe for humans?

Respiratory muscle training (RMT) has been studied in various conditions and is generally considered safe for humans. Studies have shown it can improve performance in sports and does not increase the risk of lymphedema in breast cancer survivors. ^{1 2 3 6 7}

How does Respiratory Muscle Training differ from other treatments for breast cancer?

Respiratory Muscle Training (RMT) is unique because it focuses on strengthening the muscles used for breathing, which can improve overall respiratory function and exercise capacity. Unlike traditional cancer treatments like chemotherapy or radiation, RMT is a non-invasive exercise-based therapy that may help enhance quality of life by improving breathing efficiency. ^{1 8 9 10 11}

What is the purpose of this trial?

This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for breast cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.

Research Team

Ellis Levine, MD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with breast cancer who are about to start or are currently receiving chemotherapy. Participants must be able to understand English, follow instructions, and have signed a consent form. It's not suitable for those with severe illnesses like heart failure, active infections, or mental health conditions that could affect participation.

Inclusion Criteria

Able to speak, read and comprehend English language

Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

I can understand and follow instructions.

Exclusion Criteria

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

I have had radiation therapy to the left side of my chest.

Are pregnant or nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week Respiratory Muscle Training (RMT) program during adjuvant and neoadjuvant chemotherapy for breast cancer

12 weeks

Home-based sessions

Follow-up

Participants are monitored for changes in cardiac autonomic regulation, cardiorespiratory fitness, exercise performance, and quality-of-life

4 weeks

Treatment Details

Interventions

• Respiratory Muscle Training

Trial Overview The study tests if doing respiratory muscle training at home can reduce side effects from breast cancer treatment. This involves breathing exercises aimed at strengthening lung function and may be easier than aerobic exercise during treatment.

Participant Groups

Group I: Group II (Moderate to highter resistance RMT) Experimental Treatment 3 Interventions

Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.

Group II: Group I (low resistance RMT Group) Active Control 4 Interventions

Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) significantly improved respiratory muscle strength and exercise capacity in 20 patients with non-small cell lung cancer (NSCLC) undergoing radiotherapy, with no reported adverse events.

Key improvements were observed in maximum inspiratory muscle pressure, 6-minute walk test distance, cycle endurance test performance, and knee strength measurements after 4 weeks of training, indicating the potential benefits of IMT with PR for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. Do, J., Lee, SH., Kim, SA., et al.[2023]

Respiratory muscle training (RMT) significantly improved inspiratory muscle strength in patients with restrictive thoracic disorders, with a 27.6% increase in maximal inspiratory mouth pressure after three months of training.

Patients who underwent RMT also showed enhanced exercise performance and health-related quality of life, evidenced by increased peak oxygen consumption and improved physical performance scores compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training in restrictive thoracic disease: a randomized controlled trial. Budweiser, S., Moertl, M., Jörres, RA., et al.[2006]

Inspiratory muscle training (IMT) combined with exercise significantly reduced symptoms of dyspnea during daily life in breast cancer survivors, with a notable improvement in the Transitional Dyspnea Index score by +2.9 points compared to the control group.

The IMT group also showed substantial enhancements in respiratory muscle endurance and cycling endurance, with increases of +472 seconds and +428 seconds, respectively, indicating that IMT may be an effective adjunctive rehabilitation tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Inspiratory Muscle Training During a Rehabilitation Program in Patients With Breast Cancer: An Exploratory Double-Blind, Randomized, Controlled Pilot Study. Dahhak, A., Devoogdt, N., Langer, D.[2022]

Two weeks of inspiratory muscle training (IMT) did not preserve respiratory muscle strength in high-risk patients undergoing lung cancer surgery, as measured by maximal inspiratory and expiratory pressures, but it did improve oxygen saturation levels postoperatively.

The incidence of pneumonia was similar between the IMT group and the control group, suggesting that IMT did not significantly reduce the risk of postoperative pulmonary complications, although it showed a trend towards better oxygenation on days 3 and 4 after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Brocki, BC., Andreasen, JJ., Langer, D., et al.[2022]

Inspiratory muscle training (IMT) is feasible and shows potential effectiveness in reducing breathlessness and improving quality of life in lung cancer patients, as demonstrated in a pilot study with 46 participants over 12 weeks.

Significant improvements were observed in various outcome measures, including distress from breathlessness, coping ability, and emotional function, suggesting that IMT could be a beneficial intervention for managing symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Molassiotis, A., Charalambous, A., Taylor, P., et al.[2018]

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]

Respiratory muscle training (RMT) is an effective method to enhance athletic performance across various sports, including running, cycling, swimming, and rowing, by improving respiratory muscle function.

The physiological benefits of RMT include diaphragm hypertrophy, better neural control, and increased efficiency of respiratory muscles, which contribute to reduced breathlessness and improved overall exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advancements in Our Understanding of the Ergogenic Effect of Respiratory Muscle Training in Healthy Humans: A Systematic Review. Shei, RJ.[2023]

In a study of 26 older women (ages 60-69), 8 weeks of respiratory-muscle training led to significant improvements in respiratory muscle strength, with increases of 22% for inspiratory and 30% for expiratory strength compared to a control group.

The respiratory-muscle training group also showed enhanced exercise performance, including a 12% increase in treadmill performance time and reduced heart rate and perceived exertion during submaximal exercise, indicating that RM training can positively impact overall physical performance in older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of respiratory-muscle training on exercise in older women. Watsford, M., Murphy, A.[2022]

A one-month training program using respiratory muscle sprint-interval training (RMSIT) significantly improved respiratory muscle performance, showing greater increases in average mouth pressure compared to conventional respiratory muscle endurance training (RMET).

Both RMSIT and RMET led to similar improvements in the duration of an incremental respiratory muscle test (IncRMT), but the muscle activation patterns differed, suggesting that RMSIT may provide a more efficient training method for enhancing respiratory muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sprint-Interval and Endurance Respiratory Muscle Training Regimens. Schaer, CE., Wüthrich, TU., Beltrami, FG., et al.[2019]

In a study of 24 subjects, both resistive respiratory muscle training (RRMT) and endurance respiratory muscle training (ERMT) improved cycling performance at high altitude, increasing time to exhaustion despite not affecting maximum oxygen consumption (Vo2max).

RRMT significantly enhanced maximum inspiratory and expiratory pressures, while ERMT improved respiratory endurance, indicating that different types of respiratory muscle training can benefit performance under hypoxic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endurance and Resistance Respiratory Muscle Training and Aerobic Exercise Performance in Hypobaric Hypoxia. Wheelock, CE., Hess, HW., Johnson, BD., et al.[2022]

In a pilot study involving 12 competitive wheelchair racing athletes, respiratory muscle endurance training (RMET) significantly improved the athletes' 10-km time-trial performance, with times decreasing from 27.1 minutes to 24.1 minutes after 30 sessions of training.

The training group also showed a significant increase in respiratory muscle endurance, while the control group did not experience any improvement, indicating that RMET can enhance both respiratory function and exercise performance in wheelchair athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of respiratory muscle endurance training on wheelchair racing performance in athletes with paraplegia: a pilot study. Mueller, G., Perret, C., Hopman, MT.[2008]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. [2023]

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

Respiratory muscle training in restrictive thoracic disease: a randomized controlled trial. [2006]

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

Adjunctive Inspiratory Muscle Training During a Rehabilitation Program in Patients With Breast Cancer: An Exploratory Double-Blind, Randomized, Controlled Pilot Study. [2022]

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

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. [2022]

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

The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. [2018]

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

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

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

Recent Advancements in Our Understanding of the Ergogenic Effect of Respiratory Muscle Training in Healthy Humans: A Systematic Review. [2023]

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

The effects of respiratory-muscle training on exercise in older women. [2022]

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

Effects of Sprint-Interval and Endurance Respiratory Muscle Training Regimens. [2019]

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

Endurance and Resistance Respiratory Muscle Training and Aerobic Exercise Performance in Hypobaric Hypoxia. [2022]

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

Effects of respiratory muscle endurance training on wheelchair racing performance in athletes with paraplegia: a pilot study. [2008]