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Home-based Respiratory Muscle Training for Cancer Treatment Side Effects

This study is looking at whether home-based respiratory muscle training (RMT) can help reduce side effects for people undergoing cancer treatment. RMT involves breathing exercises to strengthen your breathing muscles. The study focuses on patients with breast, head and neck, or lung cancer who are receiving chemotherapy, immunotherapy, or radiation. Researchers want to see if RMT can improve heart and lung health, exercise ability, and quality of life, which can be affected by cancer treatments. They are also looking at how RMT might impact symptoms like stress, fatigue, and shortness of breath. You would be randomized to receive either lower or higher resistance RMT.

Study design
This interventional study plans to enroll 130 participants. Participants will be randomized into two groups, one receiving lower resistance RMT and the other higher resistance RMT.
What's involved
You would undergo respiratory muscle training for 12 weeks. You would also wear an accelerometer and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
The study measures participation and adherence to RMT for up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05787834

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

Recruiting
NAAges 21+InterventionalSupportive care
Roswell Park Cancer Institute
~130 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Best PracticeMedical Device Usage and EvaluationRespiratory Muscle TrainingSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who participate in the study
Measured over Up to 12 weeks
+3 more outcomes measured

Conditions

Breast Carcinoma
Head and Neck Cancer
Lung Cancer

Explore related trials

Breast CarcinomaLung CarcinomaMalignant Head and Neck NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ellis Levine, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

ASK RPCI
[email protected]
1-877-275-7724
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients who participate in the studyUp to 12 weeks
  • Proportion of patients who remain on studyUp to 12 weeks
  • Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/weekUp to 12 weeks

    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 sessionsUp to 12 weeks

    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.