NCT05787834

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

Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Medical Device Usage and Evaluation	Wear accelerometer
PROCEDURE	Respiratory Muscle Training	Undergo RMT
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2023-10-16
• Primary completion: 2028-10-16
• Completion: 2029-10-16
• First posted: 2023-03-28
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States