Lung Carcinoma
Conditions
Brief summary
This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.
Detailed description
PRIMARY OBJECTIVES: I. Evaluate the feasibility of delivering a home-based AE and RMT program in individuals at high risk for lung cancer. II. Assess the effects of AE and RMT on patient-reported outcomes (PROs), including QoL, fatigue, dyspnea, performance metrics such as respiratory muscle strength and lower extremity strength; the 6-minute walk test; and daily activity levels in high-risk individuals. III. Investigate whether RMT and/or AE improve peripheral and exhaled biomarkers associated with lung injury, inflammation, and/or oxidative stress. OUTLINE: Participants scheduled for a computed tomography (CT) scan are assigned to cohort A, participants who call the New York State Quitline (NYSQL) are assigned to cohort B. COHORT A: Participants are randomized to 1 of 3 arms. ARM I: Participants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call once a week (QW) to provide support, enhance safety, and promote training compliance on study. ARM II: Participants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. ARM III: Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks. COHORT B: Participants are randomized to 1 of 2 arms. ARM IV: Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. ARM V: Participants receive education on AE and RMT as in arm III on study. Additionally, all patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. After completion of study intervention, participants may be optionally followed up at week 24.
Interventions
PROCEDUREAccelerometry
Ancillary studies
OTHERAerobic Exercise
Complete tailored intensity AE cycling sessions
PROCEDUREBiospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
OTHEREducational Intervention
Receive AE and RMT education
OTHERElectronic Health Record Review
Ancillary studies
OTHERPhysical Performance Testing
Ancillary studies
PROCEDURERespiratory Muscle Training
Complete RMT sessions
OTHERSupportive Care
Receive virtually supervised session/call
OTHERSurvey Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 50 years old * Current smoker with a ≥ 20-pack-years history * Former smoker within the past 15 years, with a history of ≥ 20 pack-years (CT scan cohort only) * Participant must be able to speak, read and comprehend English language * Cognitively capable of following direction and performing the intervention * 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
* Any previous lung cancer diagnoses and or undergoing treatment for any cancer * Recent pneumonia, bronchitis, or other inflammatory conditions in the lungs, including but limited to chronic obstructive pulmonary disease (COPD) and/or asthma exacerbation within the previous 6 months * Have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance rate (Feasibility) | Up to 12 weeks | The primary objective is in the feasibility of conducting the respiratory muscle training (RMT) and aerobic exercise (AE) intervention relative to the sham control. In the RMT group, overall compliance (e.g., compliant at all time points) will be estimated using 90% confidence intervals (CIs) obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) compliance rates. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors using a generalized estimating equation logistic regression model (autoregressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend. |
| Adherence rate (Feasibility) | Up to 12 weeks | The primary objective is in the feasibility of conducting the RMT and AE intervention relative to the sham control. In the RMT group, overall adherence (complete ≥ 70% of sessions) rates will be estimated using 90% CIs obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) adherence rates. |
| Assessing inspiratory and expiratory muscle strength | At baseline, 6 weeks, and 12 weeks | Participants will complete 3 sets of 15 breaths, 5 days/week using commercially available Power Lung. resistance will be increased 5-10% every week . Participants will rate and log their effort |
| change in St. George Respiratory Questionnaire (SGRQ) | At baseline, 6 weeks, and 12 weeks | The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life. |
| Functional capacity | At baseline, 6 weeks, and 12 weeks | Measured by the 6-Minute Walk Test. Will be summarized at pre-, 6-week and post-intervention timepoints, regardless of treatment regimen, using the appropriate descriptive statistics and graphically summarized. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Comparisons at the 6-week and 3-month follow-up visits will be secondary and will only be performed if the primary comparison for the corresponding endpoint reaches statistical significance. For cohort A, Bonferroni's correction will be applied to adjust for three pairwise comparisons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity strength | At baseline and 12 weeks | Measured using the 30-Second Sit-to-Stand Test. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. |
| Physical performance | At baseline and 12 weeks | Measured using the Short Physical Performance Battery. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. |
| Physical activity levels | Up to 12 weeks | daily step counts and minutes at various intensity levels will be monitored with an activity tracker. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. |
| Patient-reported outcomes on Fatigue | At baseline and 12 weeks | he Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is 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". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the lower the score the greater the fatigue severity |
| High-sensitivity C-reactive protein | At baseline and 12 weeks | The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. |
| Cardiac biomarkers | At baseline and at 12 weeks | Will assess cardiac biomarkers, such as high-sensitivity troponin T and N-terminal pro-brain natriuretic peptide. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Biomarker data will be appropriately transformed prior to analysis to meet model assumptions. |
| Dyspnea patient reported response | Baseline and at 12 weeks | he Dyspnea-12 describes the different qualitative dimensions of breathlessness. Each 12- item (seven for the physical and five for the affective components) score ranges from 'none' (score 0) to 'severe' (score 3) with a total score ranging from 0 to 36 (lower is better), a physical score ranging from 0 to 21 and an affective score ranging from 0 to 15 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew D Ray
Roswell Park Cancer Institute
Outcome results
None listed