RecruitingInterventional

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

NCT ID: NCT05787834Sponsor: Roswell Park Cancer InstituteLast updated: 2026-05-29

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.

Arms & interventions

OtherBest Practice
Receive usual care
OtherMedical Device Usage and Evaluation
Wear accelerometer
ProcedureRespiratory Muscle Training
Undergo RMT
OtherSurvey Administration
Ancillary studies

Outcome measures

Primary

Proportion of patients who participate in the study
Time frame: Up to 12 weeks
Proportion of patients who remain on study
Time frame: Up to 12 weeks
Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week
Overall compliance rates (compliance at all time points) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, breast cancer (BC) treatment received, treatment side-effects) using a generalized estimating equation (GEE) logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
Time frame: Up to 12 weeks
Proportion of patients who perform > 70% of their RMT sessions
Adherence rates (completion of \>= 70% of sessions) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, BC treatment received, treatment side-effects) using a GEE logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
Time frame: Up to 12 weeks

Secondary

Change in Functional Capacity
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Lower body strength
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Dyspnea
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Fatigue
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Quality of life
Time frame: At baseline, 6 weeks, and 12 weeks
Sleep quality
Time frame: At baseline, 6 weeks, and 12 weeks
Anxiety
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of stress
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of depression
Time frame: At baseline, 6 weeks, and 12 weeks
Measures of fitness
Time frame: At baseline, 6 weeks, and 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting

Ellis Levine, MD · Contact

716-845-3152 Ellis.Levine@roswellpark.org

Ellis Levine, MD · Principal Investigator