Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
Launched by YONSEI UNIVERSITY · Mar 19, 2025
Trial Information
Current as of May 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of radiation treatment on the heart in patients who are receiving thoracic radiotherapy for solid tumors, such as lung cancer. The goal is to find out if the amount of radiation exposure can increase the risk of heart problems, specifically a type of irregular heartbeat called atrial fibrillation. To do this, researchers will use wearable devices that monitor heart activity in real-time, allowing them to track any changes over time. The study will include 111 patients, and information will be collected at 3, 12, and 24 months after treatment to see if there are any heart issues related to the radiation.
To participate in this study, patients need to be adults aged 20 or older who are undergoing radiation therapy aimed at curing their cancer and are considered at moderate to high risk for heart problems from radiation. They should also be able to understand and sign a consent form. Participants can expect regular check-ups and heart monitoring as part of the trial. This research hopes to improve how doctors can recognize and manage heart issues caused by radiation, ultimately making treatment safer and more effective for patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with solid tumors requiring thoracic radiotherapy
- • Undergoing curative-intent radiotherapy
- • Expected survival \> 4 months
- • Adults aged ≥ 20 years
- • ECOG performance status 0-2
- • Classified as moderate-to-high risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines
- • Able to read, understand, and sign the informed consent form
- Exclusion Criteria:
- • History of prior thoracic radiotherapy
- • Inability to provide informed consent or refusal to participate
- • Pre-existing arrhythmia diagnosed through medical history or pre-treatment evaluation
- • Expected survival ≤ 4 months
- • Classified as low risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines
- • Unsuitability for Wearable CR device use
About Yonsei University
Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported