Breast Carcinoma, Head and Neck Cancer, Lung Cancer
Conditions
Brief 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 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: 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.
Interventions
OTHERBest Practice
Receive usual care
OTHERMedical Device Usage and Evaluation
Wear accelerometer
PROCEDURERespiratory Muscle Training
Undergo RMT
OTHERSurvey Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTASK RPCI
PRINCIPAL_INVESTIGATOREllis Levine, MD
Roswell Park Cancer Institute
Outcome results
None listed