NCT07685938 Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
| NCT ID | NCT07685938 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Chest Wall Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-12 |
| Primary Completion | 2029-02 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-08-12 with a primary completion date of 2029-02.
⚠ 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
Radiation therapy is an essential treatment for tumors in the chest area, including breast, lung, esophageal, mediastinal cancers, and spine metastases. Although technical advances have reduced treatment-related illness and death, radiation exposure to the heart can still cause substantial rates of radiation-induced heart disease (RIHD) among survivors. For example, about 21% of non-small cell lung cancer patients receiving a mean heart dose of 20 Gy or higher experience major adverse cardiac events (MACE) within 2 years. In breast cancer patients, the risk of MACE increases by about 7% for each additional Gy of mean heart dose. There is currently no established medication strategy to prevent or reduce RIHD. Preclinical and clinical studies show that statins and angiotensin-converting enzyme (ACE) inhibitors may help reduce radiation-induced heart disease (RIHD). Statins and ACE inhibitors are generally well tolerated, available as generic drugs, and commonly used to help prevent cardiovascular disease. They may protect the heart by reducing damage to blood vessel lining (endothelial damage), microvascular dysfunction, atherosclerosis, reduced blood flow (ischemia), and fibrosis (scarring). This study is a prospective, randomized, placebo-controlled phase II hybrid decentralized trial. Patients receiving standard radiation therapy and expected to receive an equivalent dose of at least 25 Gy (EQD2) to at least 10% of the heart will be randomly assigned to receive either: * placebo, or * Atorvastatin 20 mg plus Lisinopril 5 mg daily. The medications will be taken during radiation therapy and continued for 6 months after treatment. The study aims to determine whether the intervention can reduce radiation-related decreases in blood flow to the heart, measured using myocardial perfusion imaging, such as positron emission tomography (PET), which is commonly used to evaluate the risk of coronary heart disease.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA * authorization for release of personal health information. * Subjects is willing and able to comply with study procedures based on the * judgement of the investigator. * Consent for serial blood draws and consent for use of biological specimens. * Age ≥ 18 years at the time of consent Exclusion Criteria: * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Pre-existing use of a statin or ACE-inhibitor * Pre-existing hypotension
Contact & Investigator
Shivani Sud, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07685938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chest Wall Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07685938 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07685938 currently recruiting?
Yes, NCT07685938 is actively recruiting participants. Contact the research team at claire_kowalczyk@med.unc.edu for enrollment information.
Where is the NCT07685938 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07685938 clinical trial?
NCT07685938 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Shivani Sud, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 60 participants.