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.
Additional locations may be listed on ClinicalTrials.gov for NCT05787834.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Ellis G. Levine
Phone: 716-845-3152
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 usual care for 12 weeks on study. After 12 weeks, patients may crossover to receive RMT using a respiratory muscle training device for 6 weeks. Patients wear an activity monitor and may optionally undergo blood sample collection.
GROUP II: Patients undergo RMT using a respiratory muscle training device for 12 weeks on study. Patients wear an activity monitor and may optionally undergo blood sample collection.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorEllis G. Levine
