Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Best Practice

Medical Device Usage and Evaluation

Respiratory Muscle Training

Survey Administration

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (low resistance RMT Group)

Group II (Moderate to highter resistance RMT)

Arm Description

Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance

Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.

Outcomes

Primary Outcome Measures

Proportion of patients who participate in the study

Proportion of patients who remain on study

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.

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.

Secondary Outcome Measures

Change in Functional Capacity

Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.

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.

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.

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)

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.

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.

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.

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

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.

Measures of fitness

Will be measured with a submaximal exercise test. A 6 minute cycling exercise test.

Full Information

NCT ID

NCT05787834

First Posted

February 23, 2023

Last Updated

October 23, 2023

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT05787834

Brief Title

Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer

Official Title

Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 16, 2023 (Actual)

Primary Completion Date

October 16, 2028 (Anticipated)

Study Completion Date

October 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I (low resistance RMT Group)

Arm Type

Active Comparator

Arm Description

Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance

Arm Title

Group II (Moderate to highter resistance RMT)

Arm Type

Experimental

Arm Description

Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.

Intervention Type

Other

Intervention Name(s)

Best Practice

Other Intervention Name(s)

standard of care, standard therapy

Intervention Description

Receive usual care

Intervention Type

Other

Intervention Name(s)

Medical Device Usage and Evaluation

Intervention Description

Wear accelerometer

Intervention Type

Procedure

Intervention Name(s)

Respiratory Muscle Training

Other Intervention Name(s)

RMT

Intervention Description

Undergo RMT

Intervention Type

Other

Intervention Name(s)

Survey Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Proportion of patients who participate in the study

Time Frame

Up to 12 weeks

Title

Proportion of patients who remain on study

Time Frame

Up to 12 weeks

Title

Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week

Description

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

Title

Proportion of patients who perform > 70% of their RMT sessions

Description

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

Secondary Outcome Measure Information:

Title

Change in Functional Capacity

Description

Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.

Time Frame