Recruiting

Respiratory Muscle Training

Sponsor:

Roswell Park Cancer Institute

Code:

NCT05787834

Conditions

Breast Carcinoma

Head and Neck Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Medical Device Usage and Evaluation

Respiratory Muscle Training

Survey Administration

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Head and Neck Cancer

Lung Cancer

Study ID

NCT05787834

Start date

Oct 16, 2023

Status verified date

Aug, 2026

Completion date

Oct 16, 2029

Anticipated

Primary completion date

Oct 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able and willing to provide written informed consent
  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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.

Interventions

Best Practice

Receive usual care

Medical Device Usage and Evaluation

Wear accelerometer

Respiratory Muscle Training

Undergo RMT

Survey Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

ASK RPCI

1-877-275-7724askrpci@roswellpark.org

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ellis Levine, MD

716-845-3152Ellis.Levine@roswellpark.org

Principal Investigator:

Ellis Levine, MD

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-19.