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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
- ClinicalTrials.gov ID
- NCT07685938
- Acronym / sponsor ID
- LCCC2239-DCT
- Conditions
- Chest Wall Tumor, Breast Cancer, Lung Cancer, Esophageal Cancer, Mediastinal Cancers, Spine Metastases
- Keywords
- radiation therapy, morbidity, mortality, radiation induced heart disease, major adverse cardiac events, placebo-controlled, angiotensin-converting enzyme (ACE) inhibitors, statins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| statins and angiotensin-converting enzyme (ACE) inhibitors | Experimental | Drug: Atorvastatin and LisinoprilPatients 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients expected to receive ≥25 Gy equivalent dose in 2 Gy fractions (EQD2) to at least 10% of the heart will take inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin and LisinoprilPatients will receive statins and angiotensin-converting enzyme (ACE) inhibitors. | Drug | statins and angiotensin-converting enzyme (ACE) inhibitors |
| PlaceboPatients will receive placebo. | Drug | Placebo |
Primary outcome
Percent difference in the radiation (RT)-induced reduction of myocardial perfusion
Time frame: Pre radiation therapy and 6-month post radiation therapy
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chest Wall Tumor
RecruitingObservational study
Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study
Breast Cancer, Oncoplastic Breast Surgery
RecruitingEarly Phase 1
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Metastatic Triple-Negative Breast Carcinoma, Breast Cancer
RecruitingPhase 2
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Advanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Active, not recruitingPhase 2
Proton Radiation for Stage II/III Breast Cancer
Breast Cancer, Breast Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivani Sud, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Kowalczyk (984-974-0000, claire_kowalczyk@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent difference in the radiation (RT)-induced reduction of myocardial perfusion (time frame: Pre radiation therapy and 6-month post radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.