Breast CarcinomaNCT05787834
Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer
A study testing Best Practice, Medical Device Usage and Evaluation and Respiratory Muscle Training in people with Breast Carcinoma and Head and Neck Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Carcinoma, Head and Neck Cancer, Lung Cancer
- What is being tested?
- Best Practice, Medical Device Usage and Evaluation and Respiratory Muscle Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 16 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Age >= 21 years old
- Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)
- Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation
- Treated at Roswell Park Comprehensive Cancer Center
Who cannot join
- Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline
- Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Ellis Levine, MD, 716-845-3152, Ellis.Levine@roswellpark.org
Ellis Levine, MD
About this study
Official title: Respiratory Muscle Training During Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Breast Carcinoma, Head and Neck Cancer, Lung Cancer
- Being tested
- Best Practice, Medical Device Usage and Evaluation, Respiratory Muscle Training, Survey Administration
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Medical Device Usage and EvaluationOther
Wear accelerometer
Respiratory Muscle TrainingProcedure or surgery
Also called RMT
Undergo RMT
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (low resistance RMT Group) | Active comparator | Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance Receives: Other: Best Practice; Other: Medical Device Usage and Evaluation; Procedure: Respiratory Muscle Training; Other: Survey Administration |
| Group II (Moderate to highter resistance RMT) | Experimental | Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study. Receives: Other: Medical Device Usage and Evaluation; Procedure: Respiratory Muscle Training; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who participate in the study
Measured: Up to 12 weeks
Proportion of patients who remain on study
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (10)
Change in Functional Capacity
Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At baseline, 6 weeks, and 12 weeks
Measures of fitness
Will be measured with a submaximal exercise test. A 6 minute cycling exercise test.
Measured: At baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start16 Oct 2023
- Primary completion16 Oct 2028 (estimated)
- Study completion16 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellis Levine, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787834
- Sponsor's protocol ID
- I-3364822
- Other IDs
- NCI-2023-01256, I-3364822
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Training During Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity
- ClinicalTrials.gov ID
- NCT05787834
- Acronym / sponsor ID
- I-3364822
- Conditions
- Breast Carcinoma, Head and Neck Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 16 Oct 2029 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (low resistance RMT Group) | Active comparator | Other: Best Practice, Other: Medical Device Usage and Evaluation, Procedure: Respiratory Muscle Training, Other: Survey AdministrationPatients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance |
| Group II (Moderate to highter resistance RMT) | Experimental | Other: Medical Device Usage and Evaluation, Procedure: Respiratory Muscle Training, Other: Survey AdministrationPatients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide written informed consent
- Age >= 21 years old
- Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)
- Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation
- Treated at Roswell Park Comprehensive Cancer Center
Key exclusion criteria (3 listed)
- Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline
- Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Group I (low resistance RMT Group) |
| Medical Device Usage and EvaluationWear accelerometer | Other | Group I (low resistance RMT Group), Group II (Moderate to highter resistance RMT) |
| Respiratory Muscle TrainingAlso: RMTUndergo RMT | Procedure or surgery | Group I (low resistance RMT Group), Group II (Moderate to highter resistance RMT) |
| Survey AdministrationAncillary studies | Other | Group I (low resistance RMT Group), Group II (Moderate to highter resistance RMT) |
Primary outcome
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
Time frame: Up to 12 weeks
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.
Proportion of patients who perform > 70% of their RMT sessions
Time frame: Up to 12 weeks
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.
10 secondary outcomes
Change in Functional Capacity
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Lower body strength
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Dyspnea
Time frame: At baseline, 6 weeks, and 12 weeks
Assess Fatigue
Time frame: At baseline, 6 weeks, and 12 weeks
Change in Quality of life
Time frame: At baseline, 6 weeks, and 12 weeks
Sleep quality
Time frame: At baseline, 6 weeks, and 12 weeks
Anxiety
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of stress
Time frame: At baseline, 6 weeks, and 12 weeks
Self-reported measures of depression
Time frame: At baseline, 6 weeks, and 12 weeks
Measures of fitness
Time frame: At baseline, 6 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellis Levine, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Medical Device Usage and Evaluation and Respiratory Muscle Training in people with Breast Carcinoma and Head and Neck Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK RPCI (1-877-275-7724, askrpci@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who participate in the study (time frame: Up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.