Evaluating heart risks in breast cancer patients after radiation therapy
Watch Your HeaRT Study - Screening and Risk Analysis of Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer
This study is testing how radiation therapy for breast cancer might affect heart health in women by checking for heart rhythm problems over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Institut de Radioprotection et de Surete Nucleaire Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06073509 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of atrial fibrillation and other cardiac arrhythmias in women who have undergone radiation therapy for breast cancer. Participants will receive regular follow-up care from radiation oncologists for five years, along with cardiovascular screenings that utilize connected technology to monitor heart health. The study will also analyze the absorbed radiation doses to various heart structures using advanced deep learning algorithms. By identifying these potential cardiac issues, the study seeks to improve patient outcomes and awareness of radiation-related heart risks.
Who should consider this trial
Good fit: Ideal candidates are women aged 65 and older who received radiation therapy for breast cancer at Clinique Pasteur between 2018 and 2020.
Not a fit: Patients with a history of atrial fibrillation or other cancers prior to breast cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and management of heart health in breast cancer survivors post-radiation therapy.
How similar studies have performed: While the approach of using connected technology for monitoring heart health is innovative, similar studies have shown the importance of cardiovascular screening in cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women treated surgically for primary cancer of the left or right breast and for whom adjuvant treatment is RT with irradiation of the breast or chest wall and possibly irradiation of lymph node chains, * Adjuvant radiotherapy performed at Clinique Pasteur between 2018 and 2020, * 5-year post-RT follow-up radiation oncologist consultation performed at Clinique Pasteur * Age ≥ 65 years at the time of the 5-year post-RT follow-up consultation * Own a smartphone and able to understand and use digital tools alone and/or with the help of a caregiver ; * Patient having consented to connected follow-up, * Be affiliated to a social security scheme or equivalent * Be willing to participate in the study and have signed the consent form Exclusion Criteria: * History of cancer before breast cancer RT * Recurrence of breast cancer or other cancer treated after breast cancer RT * History of atrial fibrillation prior to breast cancer RT
Where this trial is running
Toulouse
- Clinique Pasteur — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Sophie Jacob, PhD
- Email: sophie.jacob@irsn.fr
- Phone: +33561145608
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.