NCT06869447 · Roswell Park Cancer Institute
New York Better Breathing Study
What this study is 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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
OTHER
Electronic Health Record Review
Ancillary studies
OTHER
Medical Device Usage and Evaluation
Use Power Lung breathing device
OTHER
Questionnaire Administration
Ancillary studies
PROCEDURE
Respiratory Muscle Training
Participate in RMT sessions
PROCEDURE
Sham Intervention
Participate in sham sessions
Primary outcome measures
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
Time frame: Up to 12 weeks
Compliance will be estimated using 90% confidence intervals (CIs) obtained by Jeffreys' prior method. Will be modeled as a function of time (e.g., week) and prespecified exogenous factors (e.g., baseline age, pre-intervention dyspnea scores, self-reported history of exercise, lung cancer treatment received, treatment side-effects) using a GEE (Generalized Estimating Equations) logistic regression model (autoregressive covariance structure). Will also be explored with data stratified by race and gender.
Proportion of planned sessions completed (Adherence) (Aim 1)
Time frame: Up to 12 weeks
Adherence will be defined as the number of sessions completed divided by the total number of sessions planned (70% of the 42/60 sessions). Will be estimated using 90% CIs obtained by Jeffreys' prior method. Will also be explored with data stratified by race and gender.
Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1)
Time frame: Up to 12 weeks
Tolerability ratio will be assessed using Relative Dose Intensity and rate of lost to follow-up and discontinuation.
Inspiratory muscle strength (Aim 2)
Time frame: Up to 12 weeks
Will perform remote respiratory muscle strength testing with a handheld device (Leaton, China) to measure diaphragm strength. All will be done per American Thoracic Society guidelines. A minimum of 3 trials with 5% of each will be required. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using linear mixed models (LMMs).
Change in dyspnea (Aim 2)-Dyspnea-12 survey
Time frame: Through study completion up to 7 months
Will be measured using the Dyspnea-12 survey survey that measures recent breathlessness with 12 questions related to dyspnea, each evaluated on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe) that indicate how troubled people are by each of these 12 topics, for a total possible score ranging from 0 to 36, where lower scores relate to better outcomes.- Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using LMMs.
Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea
Time frame: Through study completion up to 7 months
the Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea questionnaire. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using LMMs.
Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory
Time frame: Through study completion up to 7 months
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale
Time frame: Through study completion up to 7 months
s a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so".
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
All flow cytometry assessments will be performed in the Flow \& Image Cytometry Shared Resource (FICSR). A key outcome will be the quantification of immunosuppressive MDSCs, which play an important role in lung cancer prognosis. Myeloid cells (CD45+ CD11b+CD33+) will be assessed for both major human MDSC subsets, polymorphonuclear myeloid-derived suppressor cells, and monocytic MDSCs. For analysis of peripheral blood mononuclear cells, cells will first be collected over a Ficoll-Hypaque gradient, where both MDSC subsets, as well as all other immune populations analyzed will reside. Polymorphonuclear-MDSCs will be defined as CD11b+CD33+HLA-DR-CD14-CD15+CD66b+, whereas M-MDSCs will be defined as CD11b+CD33+HLA-DRlo/- CD14+CD15-CD66b-.
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
All flow cytometry assessments will be performed in the FICSR. Will be stratified based on CD4 or CD8 expression, and will be further defined by their differentiation, activation, or exhaustion states.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Buffalo, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations