Clinical trial NCT06869447: Home-Based Respiratory Muscle Training Intervention for Reducing Symptoms in Stage I-III Lung Cancer Survivors
Official title: Lung Cancer Better Breathing Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Localized Lung Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
timeFrame: Up to 12 weeks
measure: Proportion of planned sessions completed (Adherence) (Aim 1)
timeFrame: Up to 12 weeks
measure: Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1)
timeFrame: Up to 12 weeks
measure: Inspiratory muscle strength (Aim 2)
timeFrame: Up to 12 weeks
measure: Change in dyspnea (Aim 2)-Dyspnea-12 survey
timeFrame: Through study completion up to 7 months
measure: Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea
timeFrame: Through study completion up to 7 months
measure: Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory
timeFrame: Through study completion up to 7 months
measure: Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale
timeFrame: Through study completion up to 7 months
measure: Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)
timeFrame: Prior to start of 12 week program and after the end of the 12 week program
measure: Circulating levels conventional T cell populations (CD3+) (Aim 3)
timeFrame: Prior to start of 12 week program and after the end of the 12 week program
Secondary outcomes:
measure: Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)
timeFrame: Up to 12 weeks
measure: Attrition rate (Feasibility) (Aim 1)
timeFrame: At 6 and 12 weeks
measure: Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)
timeFrame: At 6 and 12 weeks
measure: Barriers to and facilitators (Aim 1)
timeFrame: At 6 and 12 weeks
measure: Satisfaction with RMT and RMT-sham sessions (Aim 1)
timeFrame: At 6 and 12 weeks
measure: Exercise related dyspnea (Aim 2)
timeFrame: Up to 3 months follow-up
measure: Change in general quality of life (QoL) (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in disease-specific QoL (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in 2-minute step test (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in 30 second sit-to-stand test (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in sleep (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in leisure-time physical activity (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in physical activity and daily steps (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in pain (Aim 2)
timeFrame: Through study completion up to 7 months
measure: Change in peak inspiratory and expiratory muscle strength (Aim 2)
timeFrame: Through study completion up to 7 months
measure: High-sensitivity C-reactive protein (Aim 3)
timeFrame: Prior to start of 12 week program and after the end of the 12 week program
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Andrew D Ray
role: PRINCIPAL_INVESTIGATOR
References: