Home-Based Respiratory Muscle Training Intervention for Reducing Symptoms in Stage I-III Lung Cancer Survivors

Roswell Park Comprehensive Cancer Center

Status: Not yet enrolling

Conditions: Stage I Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Localized Lung Carcinoma; Stage II Lung Cancer AJCC v8

Treatments: Other: Electronic Health Record Review; Procedure: Biospecimen Collection; Procedure: Sham Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Procedure: Respiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06869447

NCI-2025-01035 (Registry Identifier)

I-3969424 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years of age.
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group I (moderate/high intensity RMT)

Experimental group

Description:

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.

Treatment:

Procedure: Respiratory Muscle Training

Other: Questionnaire Administration

Other: Medical Device Usage and Evaluation

Procedure: Biospecimen Collection

Other: Electronic Health Record Review

Group II (low intensity sham RMT)

Sham Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Sham Intervention

Other: Medical Device Usage and Evaluation

Procedure: Biospecimen Collection

Other: Electronic Health Record Review