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

Official title

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

Overview

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

• Other Best Practice
  Receive usual care
• Other Medical Device Usage and Evaluation
  Wear accelerometer
• Procedure Respiratory Muscle Training
  Undergo RMT
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Proportion of patients who participate in the study [Time frame: Up to 12 weeks]
• Proportion of patients who remain on study [Time frame: Up to 12 weeks]
• Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week [Time frame: Up to 12 weeks]
• Proportion of patients who perform > 70% of their RMT sessions [Time frame: Up to 12 weeks]

Secondary outcome measures (10)

• Change in Functional Capacity [Time frame: At baseline, 6 weeks, and 12 weeks]
• Change in Lower body strength [Time frame: At baseline, 6 weeks, and 12 weeks]
• Assess Dyspnea [Time frame: At baseline, 6 weeks, and 12 weeks]
• Assess Fatigue [Time frame: At baseline, 6 weeks, and 12 weeks]
• Change in Quality of life [Time frame: At baseline, 6 weeks, and 12 weeks]
• Sleep quality [Time frame: At baseline, 6 weeks, and 12 weeks]
• Anxiety [Time frame: At baseline, 6 weeks, and 12 weeks]
• Self-reported measures of stress [Time frame: At baseline, 6 weeks, and 12 weeks]
• Self-reported measures of depression [Time frame: At baseline, 6 weeks, and 12 weeks]
• Measures of fitness [Time frame: At baseline, 6 weeks, and 12 weeks]

Eligibility criteria

Inclusion criteria

• Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT05787834 · I-3364822 · NCI-2023-01256 · I-3364822

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗