Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer
Study Details
Study Description
Brief Summary
This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for breast 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
SECONDARY OBJECTIVES:
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To determine how cardiac autonomic regulation, cardiorespiratory fitness, exercise performance, and quality-of-life (QoL) are affected by RMT during breast cancer treatment.
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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 usual care for 12 weeks on study. After 12 weeks, patients may crossover to receive RMT using a respiratory muscle training device for 6 weeks.
GROUP II: Patients undergo RMT using a respiratory muscle training device for 12 weeks on study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I (usual care) Patients receive usual care for 12 weeks on study. After 12 weeks, patients may crossover to receive RMT using a respiratory muscle training device for 6 weeks. |
Other: Best Practice
Receive usual care
Other Names:
Other: Medical Device Usage and Evaluation
Wear accelerometer
Other: Survey Administration
Ancillary studies
|
| Experimental: Group II (RMT) Patients undergo RMT using a respiratory muscle training device for 12 weeks on study. |
Other: Medical Device Usage and Evaluation
Wear accelerometer
Procedure: Respiratory Muscle Training
Undergo RMT
Other Names:
Other: Survey Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients who participate in the study [Up to 12 weeks]
- Proportion of patients who remain on study [Up to 12 weeks]
- Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week [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 [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.
Secondary Outcome Measures
- Change in Functional Capacity [At baseline, 6 weeks, and 12 weeks]
Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.
- Change in Lower body strength [At baseline, 6 weeks, and 12 weeks]
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.
- Assess Dyspnea [At baseline, 6 weeks, and 12 weeks]
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.
- Assess Fatigue [At baseline, 6 weeks, and 12 weeks]
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)
- Change in Quality of life [At baseline, 6 weeks, and 12 weeks]
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.
- Sleep quality [At baseline, 6 weeks, and 12 weeks]
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.
- Anxiety [At baseline, 6 weeks, and 12 weeks]
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.
- Self-reported measures of stress [At baseline, 6 weeks, and 12 weeks]
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
- Self-reported measures of depression [At baseline, 6 weeks, and 12 weeks]
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.
- Measures of fitness [At baseline, 6 weeks, and 12 weeks]
Will be measured with a submaximal exercise test. A 6 minute cycling exercise test.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
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Age >= 18 years old
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Cognitively capable of following direction and performing the intervention
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Able to speak, read and comprehend English language
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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:
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Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
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Prior radiation to the left chest wall
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Patients with medical frailty (clinical discretion)
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Are pregnant or nursing
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Unwilling or unable to follow protocol requirements
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Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
Investigators
- Principal Investigator: Tracey L O'Connor, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I-3364822
- NCI-2023-01256
- I-3364822