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

NCT ID: NCT05787834

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2029-10-16

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive usual care

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear accelerometer

Respiratory Muscle Training

Intervention Type: PROCEDURE

Undergo RMT

Survey Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: EXPERIMENTAL

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear accelerometer

Respiratory Muscle Training

Intervention Type: PROCEDURE

Undergo RMT

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive usual care

Intervention Type: OTHER

Medical Device Usage and Evaluation

Wear accelerometer

Intervention Type: OTHER

Respiratory Muscle Training

Undergo RMT

Intervention Type: PROCEDURE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; RMT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellis Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

ASK RPCI

Role: CONTACT

askrpci@roswellpark.org

1-877-275-7724

Facility Contacts

Ellis Levine, MD

Role: primary

Ellis.Levine@roswellpark.org

716-845-3152

Other Identifiers

NCI-2023-01256

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3364822

Identifier Type: OTHER

Identifier Source: secondary_id

I-3364822

Identifier Type: -

Identifier Source: org_study_id