Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study

Not yet recruiting

• Conditions: Cardiotoxicity; Thoracic Radiotherapy; Wearable Electronic Devices; Thoracic Neoplasms; Atrial Fibrillation

• Registration Number: NCT06897189
• Lead Sponsor: Yonsei University

Brief Summary

This prospective observational cohort study aims to assess the risk of radiation-induced cardiotoxicity in patients undergoing thoracic radiotherapy by integrating real-time arrhythmia monitoring using wearable cardiac rehabilitation (wearable CR) devices and AI-based cardiac substructure segmentation. The study will analyze radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), to identify risk factors for atrial fibrillation (AF) and other arrhythmias. Patients will receive wearable CR monitoring at 3, 12, and 24 months post-radiotherapy, with cardiology follow-up and intervention based on standard clinical guidelines. The study will recruit 111 patients over three years, with a two-year follow-up after radiotherapy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary outcomes including any-grade arrhythmia rates, arrhythmia burden, and survival analysis. By establishing a prospective thoracic radiotherapy patient cohort, this study aims to identify dose-related risk factors, improve early detection and management of radiation-induced arrhythmias, and provide evidence-based strategies to enhance treatment safety and efficacy.

Detailed Description

"This prospective observational cohort study aims to assess the risk of radiation-induced arrhythmias in patients undergoing thoracic radiotherapy for solid tumors, integrating real-time cardiac monitoring with wearable cardiac rhythm (Wearable CR) devices and AI-based cardiac substructure segmentation. The study will recruit 111 patients over three years, with a two-year follow-up post-radiotherapy. Patients will undergo Wearable CR monitoring at 3, 12, and 24 months, facilitating early detection and intervention based on standard cardiology guidelines. Radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), will be analyzed to evaluate correlations with atrial fibrillation (AF) and other arrhythmias. AI-driven segmentation will aid in optimizing dose distribution to minimize cardiotoxicity while maintaining treatment efficacy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary endpoints including any-grade arrhythmia rates, arrhythmia burden, and survival outcomes. All enrolled patients will receive standard radiotherapy protocols tailored to their respective cancer types, ensuring treatment consistency while assessing the impact of radiation on any kinds of cardiotoxicities.

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2030-02-16
• Study Completion: 2030-02-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy	Up to 2 years post-radiotherapy	The proportion of patients who develop Grade 3 or higher atrial fibrillation within 2 years following thoracic radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy	p to 2 years post-radiotherapy	The proportion of patients experiencing any grade of atrial fibrillation within 2 years of radiotherapy.
Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy	Up to 2 years post-radiotherapy	The proportion of patients who develop any type of arrhythmia within 2 years of radiotherapy.
ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy	Up to 2 years post-radiotherapy	Classification and frequency analysis of different types of arrhythmias detected within 2 years after radiotherapy.
Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy	Up to 3 months post-radiotherapy	The proportion of patients who develop any-grade arrhythmia within 3 months after radiotherapy.
Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy	Up to 1 year post-radiotherapy	The proportion of patients experiencing any-grade arrhythmia within 1 year of radiotherapy.
Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)	Up to 2 years post-radiotherapy	Time from radiotherapy to death from any cause, CSS: Time from radiotherapy to death due to cancer, PFS: Time from radiotherapy to disease progression or death from any cause.

Trial Locations

Locations (1)

Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of