Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Other: Medical Device Usage and Evaluation; Other: Survey Administration; Procedure: Respiratory Muscle Training; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05787834

I-3364822 (Other Identifier)

NCI-2023-01256 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. To assess the feasibility of delivering a 12-week RMT program during adjuvant and neoadjuvant chemotherapy used to treat breast cancer.

SECONDARY OBJECTIVES:

I. To determine how cardiac autonomic regulation, cardiorespiratory fitness, exercise performance, and quality-of-life (QoL) are affected by RMT during breast cancer treatment.

II. To assess how RMT affects patient reported symptoms linked to sympathetic overactivation such as stress, fatigue, dyspnea, when performed during chemotherapy.

EXPLORATORY OBJECTIVE:

I. To determine if RMT reduces circulating biomarkers of autonomic dysfunction, inflammation, and cardiac injury in breast cancer patients undergoing treatment.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: patients receive lower resistance RMT using a respiratory muscle training device for 12 weeks.

GROUP II: Patients undergo higher resistance RMT using a respiratory muscle training device for 12 weeks on study.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
• Age >= 18 years old
• Cognitively capable of following direction and performing the intervention
• 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

• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
• Prior radiation to the left chest wall
• Patients with medical frailty (clinical discretion)
• Are pregnant or nursing
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Group I (low resistance RMT Group)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Procedure: Respiratory Muscle Training

Other: Survey Administration

Other: Medical Device Usage and Evaluation

Group II (Moderate to highter resistance RMT)

Experimental group

Description:

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

Treatment:

Procedure: Respiratory Muscle Training

Other: Survey Administration

Other: Medical Device Usage and Evaluation