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NCT06869447 | RECRUITING | Localized Lung Carcinoma

New York Better Breathing Study
Sponsor:

Roswell Park Cancer Institute

Brief 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.

Condition or disease

Localized Lung Carcinoma

Stage I Lung Cancer AJCC v8

Stage II Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Intervention/treatment

Biospecimen Collection

Electronic Health Record Review

Medical Device Usage and Evaluation

Questionnaire Administration

Respiratory Muscle Training

Sham Intervention

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Masking Description : The patients will be blinded to their group assignment.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Lung Cancer Better Breathing Study
Actual Study Start Date : 2025-12-15
Estimated Primary Completion Date : 2028-03-15
Estimated Study Completion Date : 2028-03-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age ≥ 18 years of age.
  • * Able to speak, read and comprehend the English language
  • * Self-identify as non-Hispanic Black or White.
  • * Are \< 15 months of histologically confirmed invasive, non-metastatic, lung cancer diagnosis.
  • * Have received surgical treatment (primarily stage I, II and III) and have completed all cancer treatments (surgery, chemotherapy, radiation).
  • * Willing to provide biospecimen samples for the study (blood) which will be collected in the comfort of the patient's home by a mobile phlebotomy group.
  • * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria
  • * Participant is metastatic (stage IV) at study entry.
  • * Has contraindications for respiratory muscle training (e.g., recent pulmonary embolism, aortic aneurysm, current pneumothorax).
  • * Is actively engaging in a structured exercise program and/or meeting exercise guidelines.
  • * Unwilling or unable to follow protocol requirements.
  • * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study.
New York Better Breathing Study

Location Details

NCT06869447

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How to Participate

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Locations

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263