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New York Better Breathing Study

NCT ID: NCT06869447

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2028-03-15

Brief Summary

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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

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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.

Conditions

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Localized Lung Carcinoma Stage I Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The patients will be blinded to their group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Use Power Lung breathing device

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Respiratory Muscle Training

Intervention Type PROCEDURE

Participate in RMT sessions

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.

Group Type SHAM_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Use Power Lung breathing device

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Sham Intervention

Intervention Type PROCEDURE

Participate in sham sessions

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Medical Device Usage and Evaluation

Use Power Lung breathing device

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Respiratory Muscle Training

Participate in RMT sessions

Intervention Type PROCEDURE

Sham Intervention

Participate in sham sessions

Intervention Type PROCEDURE

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection RMT Sham Comparator

Eligibility Criteria

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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 \< 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew D Ray

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Facility Contacts

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Andrew D. Ray

Role: primary

Other Identifiers

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NCI-2025-01035

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3969424

Identifier Type: OTHER

Identifier Source: secondary_id

I-3969424

Identifier Type: -

Identifier Source: org_study_id