Clinical trial NCT05787834: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Proportion of patients who participate in the study
timeFrame: Up to 12 weeks
measure: Proportion of patients who remain on study
timeFrame: Up to 12 weeks
measure: Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week
timeFrame: Up to 12 weeks
measure: Proportion of patients who perform > 70% of their RMT sessions
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in Functional Capacity
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Lower body strength
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Assess Dyspnea
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Assess Fatigue
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Quality of life
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Sleep quality
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Anxiety
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Self-reported measures of stress
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Self-reported measures of depression
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Measures of fitness
timeFrame: At baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Ellis Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: