New York Better Breathing Study
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT06869447
- Status
- Recruiting
Conditions
- Localized Lung Carcinoma
- Stage I Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Electronic Health Record Review — OTHERAncillary studies
- Medical Device Usage and Evaluation — OTHERUse Power Lung breathing device
- Questionnaire Administration — OTHERAncillary studies
- Respiratory Muscle Training — PROCEDUREParticipate in RMT sessions
- Sham Intervention — PROCEDUREParticipate in sham sessions
Study Details
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.
Key Dates
- Start date
- Apr 20, 2026
- Status verified
- May 2026
- Primary completion
- Apr 15, 2028
- Completion
- Apr 15, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Group I (moderate/high intensity RMT)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.
- Sham Comparator: Group II (low intensity sham RMT)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.
Primary Outcome Measure
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1) [ Time Frame: Up to 12 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Andrew D. Ray (PRINCIPAL_INVESTIGATOR) |
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