NCT06869447

New York Better Breathing Study

Lung Cancer Better Breathing Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the effects of whether breathing exercises at home can reduce symptoms and help stage I-III lung cancer survivors stay active. Over 70% of lung cancer survivors have trouble breathing, feel tired, and have lower levels of fitness. This is often because their breathing muscles are weaker after surgery. Many survivors find it hard to exercise, which affects their quality of life and overall survival. A training program to strengthen these muscles might reduce breathing problems, lower fatigue, and improve quality of life. Staying active could also help boost the immune system to fight cancer. 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. Participating in a home-based RMT intervention may reduce symptoms from cancer or treatment in lung cancer survivors.

Detailed description

PRIMARY OBJECTIVES: I. Determine the feasibility of delivering a home-based RMT program to Black and White lung cancer survivors. II. Determine the effects of RMT on symptom management (quality of life \[QoL\], fatigue, dyspnea, sleep, etc.), performance (respiratory muscle and lower extremity strength), and physical activity in Black and White lung cancer survivors. III. Determine if RMT improves cancer related anti-tumor activity (T-cell function) and diminishes markers of immunosuppression (myeloid-derived suppressor cells \[MDSCs\], regulatory T cells) and inflammation (high-sensitivity C-reactive protein, (hsCRP) in circulation. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. GROUP II: Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion. After completion of study intervention, patients are followed up at 3 months.

Conditions

• Localized Lung Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Medical Device Usage and Evaluation	Use Power Lung breathing device
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Respiratory Muscle Training	Participate in RMT sessions
PROCEDURE	Sham Intervention	Participate in sham sessions

Timeline

• Start date: 2026-04-15
• Primary completion: 2028-04-15
• Completion: 2028-04-15
• First posted: 2025-03-11
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States