Recruiting

Respiratory Muscle Training

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06869447

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+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Medical Device Usage and Evaluation

Questionnaire Administration

Respiratory Muscle Training

Study Details

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.

Conditions

Localized Lung Carcinoma

Stage I Lung Cancer AJCC v8

Stage II Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Study ID

NCT06869447

Start date

Apr 20, 2026

Status verified date

May, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Apr 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 < 24 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 has in situ (stage 0) or metastatic (stage IV) disease 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Electronic Health Record Review

Ancillary studies

Medical Device Usage and Evaluation

Use Power Lung breathing device

Questionnaire Administration

Ancillary studies

Respiratory Muscle Training

Participate in RMT sessions

Sham Intervention

Participate in sham sessions

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 ]
  • Proportion of planned sessions completed (Adherence) (Aim 1) [ Time Frame: Up to 12 weeks ]
  • Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1) [ Time Frame: Up to 12 weeks ]
  • Inspiratory muscle strength (Aim 2) [ Time Frame: Up to 12 weeks ]
  • Change in dyspnea (Aim 2)-Dyspnea-12 survey [ Time Frame: Through study completion up to 7 months ]
  • Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea [ Time Frame: Through study completion up to 7 months ]
  • Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory [ Time Frame: Through study completion up to 7 months ]
  • Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale [ Time Frame: Through study completion up to 7 months ]
  • Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3) [ Time Frame: Prior to start of 12 week program and after the end of the 12 week program ]
  • Circulating levels conventional T cell populations (CD3+) (Aim 3) [ Time Frame: Prior to start of 12 week program and after the end of the 12 week program ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Andrew D. Ray

716-845-2381Andrew.Ray@RoswellPark.org

Principal Investigator:

Andrew D. Ray

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-05-28.