An interventional study of Best Practice and Medical Device Usage and Evaluation in Breast Carcinoma, Head and Neck Cancer and Lung Cancer, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care
This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. 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. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.
PRIMARY OBJECTIVE:
I. To assess the feasibility of delivering a 12-week RMT program during adjuvant and neoadjuvant chemotherapy used to treat breast cancer, head and neck cancer and lung cancer.
SECONDARY OBJECTIVES:
I. To determine how cardiac autonomic regulation, cardiorespiratory fitness, exercise performance, and quality-of-life (QoL) are affected by RMT during breast cancer treatment.
II. To assess how RMT affects patient reported symptoms linked to sympathetic overactivation such as stress, fatigue, dyspnea, when performed during chemotherapy.
EXPLORATORY OBJECTIVE:
I. To determine if RMT reduces circulating biomarkers of autonomic dysfunction, inflammation, and cardiac injury in breast cancer patients undergoing treatment.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: patients receive lower resistance RMT using a respiratory muscle training device for 12 weeks.
GROUP II: Patients undergo higher resistance RMT using a respiratory muscle training device for 12 weeks on study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 130 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance
Other: Best Practice · Other: Medical Device Usage and Evaluation · Procedure: Respiratory Muscle Training · Other: Survey Administration
Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.
Other: Medical Device Usage and Evaluation · Procedure: Respiratory Muscle Training · Other: Survey Administration
Receive usual care
Also known as: standard of care, standard therapy
Wear accelerometer
Undergo RMT
Also known as: RMT
Ancillary studies
Proportion of patients who participate in the study
Time frame: Up to 12 weeks
Proportion of patients who remain on study
Time frame: Up to 12 weeks
Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week
Overall compliance rates (compliance at all time points) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, breast cancer (BC) treatment received, treatment side-effects) using a generalized estimating equation (GEE) logistic regression model (auto-regressive 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.
Time frame: Up to 12 weeks
Proportion of patients who perform > 70% of their RMT sessions
Adherence rates (completion of \>= 70% of sessions) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, BC treatment received, treatment side-effects) using a GEE logistic regression model (auto-regressive 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.
Time frame: Up to 12 weeks
Change in Functional Capacity
Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Lower body strength
The Short Physical Performance Battery - PPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Dyspnea
Dyspnea will be measured by the Dyspnea-12 questionnaire which contains 12 items on a scale of 0(none), mild (1) and Severe (3) and evaluates the physical and affective dimensions of dyspnea. Higher scores represent greater severity.
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Fatigue
Fatigue will be measured using the Brief Fatigue Inventory (BFI). Each item is scored 1 (no fatigue) to 10 (as bad as you can imagine) to assess the severity of fatigue and its impact on daily functioning. A global fatigue score is obtained by averaging all the items (1-3: mild, 4-7: moderate, 8-10: severe)
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Quality of life
Quality of life collected by the EORTC Core Quality of Life Questionnaire (EORTC-QLQ-30) - a 30 question questionnaire with lower higher scores indicating a positive situation.
Time frame: At baseline, 6 weeks, and 12 weeks
Sleep quality
Will be measured by the Pittsburg Sleep Quality Index a self reported inventory to measure sleep quality. Questions are answered on 0-3 scale with higher scores indicating greater sleep pathology.
Time frame: At baseline, 6 weeks, and 12 weeks
Anxiety
The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of stress
Stress will be measured by the Perceived Stress Scale. The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of depression
Will be measured by the Centers for Epidemiology Studies Depression Scale used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.
Time frame: At baseline, 6 weeks, and 12 weeks
Measures of fitness
Will be measured with a submaximal exercise test. A 6 minute cycling exercise test.
Time frame: At baseline, 6 weeks, and 12 weeks
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Roswell Park Cancer Institute