NCT05787834NARecruiting

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

Roswell Park Cancer Institute

Start Date

10/16/2023

Completion Date

10/16/2029

Summary

This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for 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, head and neck cancer and lung 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy * Age \>= 21 years old * Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer) * Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation * Treated at Roswell Park Comprehensive Cancer Center Exclusion Criteria: * Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline * Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Interventions

OTHER

Best Practice

OTHER

Medical Device Usage and Evaluation

PROCEDURE

Respiratory Muscle Training

OTHER

Survey Administration

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Conditions

Breast CarcinomaHead and Neck CancerLung Cancer

Locations

Roswell Park Cancer Institute

Buffalo, New York 14263

United States