Home-based breathing exercises to reduce side effects in breast cancer treatment
Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity
NA · Roswell Park Cancer Institute · NCT05787834
This study is testing if a 12-week home breathing exercise program can help breast cancer patients feel better by reducing heart and lung side effects from chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05787834 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 12-week home-based respiratory muscle training (RMT) program for patients undergoing treatment for breast cancer. The program aims to minimize heart and lung-related side effects caused by chemotherapy, which can negatively impact quality of life. Participants will be randomized into two groups, receiving either lower or higher resistance RMT using a specialized device. The study will assess the feasibility of the program and its impact on cardiac function, exercise performance, and patient-reported symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented breast cancer scheduled for adjuvant or neoadjuvant chemotherapy.
Not a fit: Patients with uncontrolled illnesses, prior radiation to the left chest wall, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for breast cancer patients by reducing treatment-related side effects.
How similar studies have performed: While similar approaches have been explored, this specific home-based RMT program is relatively novel and has not been extensively tested in this patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Ellis Levine, MD — Roswell Park Cancer Institute
- Study coordinator: ASK RPCI
- Email: askrpci@roswellpark.org
- Phone: 1-877-275-7724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Carcinoma