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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how breathing exercises can help breast cancer patients reduce heart and lung side effects from cancer treatment. It focuses on a home-based method called respiratory muscle training (RMT), which involves exercises to strengthen the breathing muscles. The trial compares two groups using different resistance levels in these exercises. It suits breast cancer patients undergoing chemotherapy who can follow simple instructions in English. As an unphased trial, this study offers patients a unique opportunity to explore innovative ways to manage treatment side effects.

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 prior data suggests that respiratory muscle training is safe for breast cancer patients?

Studies have shown that respiratory muscle training (RMT) is generally well-tolerated. In breast cancer survivors who have undergone surgery, RMT combined with aerobic exercises improved breathing muscle strength without significant side effects. Research on RMT in other conditions, such as head and neck cancer, indicates it is a low-cost and simple method that can reduce symptoms without major issues. These findings suggest that RMT is generally safe, with few reports of negative effects. Therefore, it should be safe for those considering joining a trial focused on RMT for breast cancer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Respiratory Muscle Training (RMT) for breast cancer patients because it offers a novel approach to improving respiratory health, which can be compromised during treatment. Unlike conventional treatments that mainly focus on directly targeting cancer cells, RMT strengthens the muscles involved in breathing. This could potentially enhance lung function and overall quality of life for patients. The trial explores two variations: one with low resistance and another with moderate to higher resistance, allowing researchers to determine the optimal intensity for patient benefit.

What evidence suggests that respiratory muscle training is effective for minimizing side effects in breast cancer patients?

This trial will compare different levels of resistance in respiratory muscle training (RMT) for breast cancer patients. Research has shown that training the muscles used for breathing, known as RMT, can improve breathing strength in these patients. Studies have found that combining RMT with aerobic exercises enhances breathing strength in breast cancer survivors after surgery. One study found that breast cancer survivors experience more difficulty breathing during exercise than healthy individuals. RMT aims to ease breathing, potentially helping patients become more active. Performing RMT at home offers a practical way to reduce heart and lung side effects from cancer treatment. This method could be particularly beneficial for patients who find regular aerobic exercise challenging during treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Ellis Levine, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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

I can understand and follow instructions.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11070168/

Using Inspiratory Muscle Training to Improve Respiratory ... In post-operative breast cancer survivors, respiratory muscle training combined with aerobic training increases respiratory muscle strength and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11092410/

Potential Therapeutic Role of Respiratory Muscle Training in ... This study demonstrates a 20% lower peak VO2 and > 50% greater dyspnea intensity in the breast cancer group compared to controls. In addition, the results ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05787834

Home-based Respiratory Muscle Training for Minimizing ... Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer. Detailed Description.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109522000209

Adjunctive Inspiratory Muscle Training During a ... Therefore, this study aimed to evaluate the effectiveness of adjunctive IMT in symptomatic survivors of breast cancer with impaired respiratory muscle function.

5. researchgate.net researchgate.net/publication/396663539_Effectiveness_Of_Manual_Therapy_And_Respiratory_Muscle_Training_To_Improve_Pain_Posture_And_Pulmonary_Function_In_Post_Mastectomy_Patients

Effectiveness Of Manual Therapy And Respiratory Muscle ... This study aims to explore the effectiveness of combining manual therapy with respiratory muscle training for post-mastectomy women, thereby ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13756-2

Respiratory muscle training reduces painful swallowing and ... RMT is a low-cost intervention that is easy to perform among patients undergoing RT/RTCC for HNC and is likely to reduce OM pain/symptoms and opioid.