Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin and Lisinopril, Placebo.
- Who it may be relevant to
- Registry conditions: Chest Wall Tumor, Breast Cancer, Lung Cancer, Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Atorvastatin and Lisinopril
Patients will receive statins and angiotensin-converting enzyme (ACE) inhibitors. - Drug Placebo
Patients will receive placebo.
Primary outcome measures
- Percent difference in the radiation (RT)-induced reduction of myocardial perfusion [Time frame: Pre radiation therapy and 6-month post radiation therapy]
Secondary outcome measures (4)
- Percent Change in Radiation-Induced Myocardial Perfusion Reduction by Cardiac Dose: Placebo vs Statin and ACE Inhibitor Therapy [Time frame: Pre radiation therapy and 6-month post radiation therapy]
- Change in for cardiac biomarker panel [Time frame: Pre radiation therapy and 3 months and 6-month post radiation therapy]
- Correlation between cardiac stress and perfusion biomarkers and radiation dose [Time frame: Pre radiation therapy and 3 months and 6-month post radiation therapy]
- Rates of major adverse cardiac events [Time frame: At follow-up of 1, 2, and 3 years.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07685938 · LCCC2239-DCT