New York Better Breathing Study

NCT06869447 | Recruiting

• 2 other identifiers: I-3969424NCI-2025-01035
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)

  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.

  Up to 12 weeks

• Proportion of planned sessions completed (Adherence) (Aim 1)

  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.

  Up to 12 weeks

• Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1)

  Tolerability ratio will be assessed using Relative Dose Intensity and rate of lost to follow-up and discontinuation.

  Up to 12 weeks

• Inspiratory muscle strength (Aim 2)

  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).

  Up to 12 weeks

• Change in dyspnea (Aim 2)-Dyspnea-12 survey

  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.

  Through study completion up to 7 months

• Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea

  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.

  Through study completion up to 7 months

• Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory

  This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  Through study completion up to 7 months

• Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale

  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".

  Through study completion up to 7 months

• Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)

  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-.

  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)

  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.

  Prior to start of 12 week program and after the end of the 12 week program

Secondary Outcomes (16)

• Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)

  Up to 12 weeks

• Attrition rate (Feasibility) (Aim 1)

  At 6 and 12 weeks

• Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)

  At 6 and 12 weeks

• Barriers to and facilitators (Aim 1)

  At 6 and 12 weeks

• Satisfaction with RMT and RMT-sham sessions (Aim 1)

  At 6 and 12 weeks

Study Arms (2)

Group I (moderate/high intensity RMT)

EXPERIMENTAL

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.

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

Group II (low intensity sham RMT)

SHAM COMPARATOR

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group I (moderate/high intensity RMT); Group II (low intensity sham RMT)

Electronic Health Record Review OTHER

Ancillary studies

Group I (moderate/high intensity RMT); Group II (low intensity sham RMT)

Medical Device Usage and Evaluation OTHER

Use Power Lung breathing device

Group I (moderate/high intensity RMT); Group II (low intensity sham RMT)

Questionnaire Administration OTHER

Ancillary studies

Group I (moderate/high intensity RMT); Group II (low intensity sham RMT)

Respiratory Muscle Training PROCEDURE

Participate in RMT sessions

Also known as: RMT

Group I (moderate/high intensity RMT)

Sham Intervention PROCEDURE

Participate in sham sessions

Also known as: Sham Comparator

Group II (low intensity sham RMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen Handling; Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Andrew D Ray

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be blinded to their group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): April 15, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)