Chest Wall TumorPhase 2NCT07685938
Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
A Phase 2 study testing Atorvastatin and Lisinopril in people with Chest Wall Tumor and Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Wall Tumor, Breast Cancer, Lung Cancer
- What is being tested?
- Atorvastatin and Lisinopril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2026to Feb 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Claire Kowalczyk, 984-974-0000, claire_kowalczyk@med.unc.edu
Shivani Sud, MD
About this study
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.
Read more
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.
- Conditions
- Chest Wall Tumor, Breast Cancer, Lung Cancer, Esophageal Cancer, Mediastinal Cancers, Spine Metastases
- Being tested
- Atorvastatin and Lisinopril, Placebo
- Keywords
- radiation therapy, morbidity, mortality, radiation induced heart disease, major adverse cardiac events, placebo-controlled, angiotensin-converting enzyme (ACE) inhibitors, statins
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Mediastinal Neoplasms, Spinal Cord Neoplasms, Thoracic Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin and LisinoprilDrug
Patients will receive statins and angiotensin-converting enzyme (ACE) inhibitors.
PlaceboDrug
Patients will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| statins and angiotensin-converting enzyme (ACE) inhibitors | Experimental | Patients expected to receive ≥25 Gy equivalent dose in 2 Gy fractions (EQD2) to at least 10% of the heart will be treated with statins and angiotensin-converting enzyme (ACE) inhibitors. Receives: Drug: Atorvastatin and Lisinopril |
| Placebo | Placebo comparator | Patients expected to receive ≥25 Gy equivalent dose in 2 Gy fractions (EQD2) to at least 10% of the heart will take inhibitors. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent difference in the radiation (RT)-induced reduction of myocardial perfusion
Percent difference in the radiation (RT)-induced reduction of myocardial perfusion in cardiac regions receiving ≥25Gy equivalent dose in 2Gy fractions (EQD2) based on comparison of before and after RT among participants receiving placebo and statins and angiotensin-converting enzyme (ACE) inhibitors intervention.
Measured: Pre radiation therapy and 6-month post radiation therapy
Secondary outcomes (4)
Percent Change in Radiation-Induced Myocardial Perfusion Reduction by Cardiac Dose: Placebo vs Statin and ACE Inhibitor Therapy
Percent difference in radiation therapy (RT)-induced reduction of myocardial perfusion in cardiac regions receiving different radiation doses (10-20 Gy and 20-25 Gy equivalent dose in 2 Gy fractions, EQD2), based on comparison of pre-RT and 6-month post-RT myocardial perfusion imaging scans between participants receiving placebo versus statins and angiotensin-converting enzyme (ACE) inhibitors intervention.
Measured: Pre radiation therapy and 6-month post radiation therapy
Change in for cardiac biomarker panel
Change in for cardiac biomarker panel including high- sensitivity troponin, Creatine Kinase myocardial band (CK-MB) or N-terminal pro-B-type Natriuretic Peptide( NT-proBNP).
Measured: Pre radiation therapy and 3 months and 6-month post radiation therapy
Correlation between cardiac stress and perfusion biomarkers and radiation dose
Correlations between absolute values and changes in cardiac stress/perfusion biomarkers and radiation dose at the individual pixel level will be compared between the placebo and intervention groups. Cardiac perfusion imaging provides quantitative assessment of regional myocardial perfusion, and the absolute difference in RT-induced perfusion reduction between study arms will be evaluated using pre- and post-RT measurements. Changes in cardiac biomarkers, including high- sensitivity troponin, Creatine Kinase myocardial band (CK-MB) or N-terminal pro-B-type Natriuretic Peptide( NT-proBNP). will also be assessed.
Measured: Pre radiation therapy and 3 months and 6-month post radiation therapy
Rates of major adverse cardiac events
Rates of major adverse cardiac events (unstable angina, heart failure hospitalization or urgent visit, myocardial infarction, coronary revascularization, and cardiac death) will be compared between trial groups at long-term
Measured: At follow-up of 1, 2, and 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start12 Aug 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivani Sud, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685938
- Sponsor's protocol ID
- LCCC2239-DCT
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No