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Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Recruitment opened
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised
  2. Minor Start date: Jul 2026 to Aug 12, 2026
    • Site contact updated
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07685938
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Conditions
(from sponsor)
Chest Wall Tumor, Breast Cancer, Lung Cancer, Esophageal Cancer, Mediastinal Cancers, Spine Metastases, Spinal Tumor, Thoracic Cancer +1 more
Related terms Breast Neoplasms, Cardiovascular Diseases, Esophageal Neoplasms, Lung Neoplasms, Mediastinal Neoplasms, Spinal Cord Neoplasms, Thoracic Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov