Heart-friendly medicines to protect chest-area cancer patients from radiation damage
Official title: Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
Run by UNC Lineberger Comprehensive Cancer Center · NCT07685938 · Data updated 2026-11-12
This Phase 2 trial tests whether taking atorvastatin and lisinopril can reduce heart damage in adults with chest-area cancers who receive radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | August 12, 2026 |
| Main results expected | February 2029 |
| Study ends | February 2029 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07685938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with chest wall, breast, lung, esophageal, or mediastinal cancers planned for or receiving chest radiation, not currently on statins or ACE inhibitors, and able to provide consent and biological samples.
✕Probably not a fit
Patients who do not experience RIHD or who do not respond to the protective effects of statins and ACE inhibitors may not see a cardiovascular benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with chest wall, breast, lung, esophageal, or mediastinal cancers receiving radiation therapy are enrolled to see if a combination of atorvastatin and lisinopril can lower the risk of radiation-induced heart disease. The study uses an interventional design with two active meds and a placebo control to compare cardiovascular outcomes over time. Eligibility includes adults 18 and older who consent, comply with procedures, and allow blood and tissue use; those already on statins or ACE inhibitors are excluded. The trial is conducted at UNC Lineberger Comprehensive Cancer Center in Chapel Hill, with outcomes focused on major adverse cardiac events and related measures. Prior evidence in preclinical and early clinical work suggests potential heart-protective effects of these drugs when combined with radiation exposure.
Why it matters
Potential benefit: If successful, participants may experience a lower risk of heart problems related to chest-area radiation therapy.
How similar studies have gone: Prior preclinical and early clinical work has suggested potential protective effects of statins and ACE inhibitors against RIHD, but robust Phase 2 confirmation is needed.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Shivani Sud, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Claire Kowalczyk
- Email: claire_kowalczyk@med.unc.edu
- Phone: 984-974-0000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.