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 — PROCEDURE
    Undergo blood sample collection
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Medical Device Usage and Evaluation — OTHER
    Use Power Lung breathing device
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Respiratory Muscle Training — PROCEDURE
    Participate in RMT sessions
  • Sham Intervention — PROCEDURE
    Participate 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)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Andrew D. Ray
716-845-2381
Andrew D. Ray (PRINCIPAL_INVESTIGATOR)

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