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Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease

RecruitingPhase 2Ages 18 Years - anyAllUNC Lineberger Comprehensive Cancer Center
NCT07685938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 inhib

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📋 Eligibility rules (as published)
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
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What it tests

  • Atorvastatin and Lisinopril
  • Placebo
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Where

1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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