- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787834
Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer
Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity
Study Overview
Status
Conditions
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ASK RPCI
- Phone Number: 1-877-275-7724
- Email: askrpci@roswellpark.org
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Shipra Gandhi, MD
- Phone Number: 716-845-1486
- Email: Shipra.Gandhi@roswellpark.org
-
Principal Investigator:
- Shipra Gandhi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
- Age >= 18 years old
- Cognitively capable of following direction and performing the intervention
- Able to speak, read and comprehend English language
- 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:
- 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
- Prior radiation to the left chest wall
- Patients with medical frailty (clinical discretion)
- Are pregnant or nursing
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I (low resistance RMT Group)
Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance
|
Receive usual care
Other Names:
Ancillary studies
Wear accelerometer
Undergo RMT
Other Names:
|
Experimental: Group II (Moderate to highter resistance RMT)
Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.
|
Ancillary studies
Wear accelerometer
Undergo RMT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who participate in the study
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
|
Proportion of patients who remain on study
Time Frame: Up to 12 weeks
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Capacity
Time Frame: At baseline, 6 weeks, and 12 weeks
|
Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.
|
At baseline, 6 weeks, and 12 weeks
|
Change in Lower body strength
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Assess Fatigue
Time Frame: 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)
|
At baseline, 6 weeks, and 12 weeks
|
Sleep quality
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Anxiety
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Self-reported measures of stress
Time Frame: 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
|
At baseline, 6 weeks, and 12 weeks
|
Self-reported measures of depression
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Measures of fitness
Time Frame: At baseline, 6 weeks, and 12 weeks
|
Will be measured with a submaximal exercise test.
A 6 minute cycling exercise test.
|
At baseline, 6 weeks, and 12 weeks
|
Assess Dyspnea
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Change in Quality of life
Time Frame: 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.
|
At baseline, 6 weeks, and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shipra Gandhi, MD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-3364822 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2023-01256 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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