NCT05787834 Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer
| NCT ID | NCT05787834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2028-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2023-10-16 with a primary completion date of 2028-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ellis Levine, MD
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT05787834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05787834 currently recruiting?
Yes, NCT05787834 is actively recruiting participants. Contact the research team at askrpci@roswellpark.org for enrollment information.
Where is the NCT05787834 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT05787834 clinical trial?
NCT05787834 is sponsored by Roswell Park Cancer Institute. The principal investigator is Ellis Levine, MD at Roswell Park Cancer Institute. The trial plans to enroll 130 participants.