Actively Recruiting
Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study
Led by Rush University Medical Center · Updated on 2025-04-13
48
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of esomeprazole to reduce symptoms of radiation-induced esophagitis in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing thoracic radiation therapy combined with chemotherapy, with or without immunotherapy. Radiation-induced esophagitis is an inflammation of the esophagus that can significantly affect quality of life and may cause treatment interruptions or long-term complications such as esophageal stricture. This phase II study aims to provide evidence on the benefits of esomeprazole, a proton pump inhibitor with anti-inflammatory properties, in managing these symptoms during treatment. Participants will receive 40 mg of esomeprazole daily, taken as two 20 mg pills before breakfast, throughout the entire period of thoracic radiation therapy and for two weeks following its completion. The thoracic radiation therapy will be administered according to the treating physicians' discretion, combined with chemotherapy. The study includes a single treatment arm and focuses on monitoring the frequency and severity of radiation-induced esophagitis symptoms during and after treatment. During the study, researchers will collect both clinician-reported and patient-reported measures of esophagitis severity at two weeks post-radiation and three months after starting radiation therapy. They will also explore biomarkers that may predict susceptibility to radiation-induced esophagitis when using esomeprazole. Patients will be monitored for symptoms and side effects, with the primary outcome being the occurrence of grade 2 or higher esophagitis. The total duration of participation spans from the start of radiation therapy through follow-up assessments at three months.
CONDITIONS
Brief Title
Esomeprazole and Radiation Induced Esophagitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older.
- Patient or legal representative can provide written informed consent and HIPAA authorization.
- Patient is willing and able to comply with scheduled visits and treatment.
- Histopathologically confirmed diagnosis of NSCLC clinical stage III.
- Planned thoracic radiation with estimated esophageal maximum dose of at least 30 Gy combined with chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Women of childbearing potential must have a negative pregnancy test within 2 weeks of enrollment.
- Double inclusion in another trial allowed if permitted.
You will not qualify if you...
- History of gastroesophageal junction or stomach cancer.
- History of pre-existing severe or very severe dysphagia.
- History of severe liver disease or systemic lupus erythematosus.
- Interstitial nephritis.
- History of peptic ulcer disease or upper gastrointestinal bleeding.
- Thoracic radiotherapy within 2 years before enrollment.
- Known or suspected allergy or adverse reaction to proton pump inhibitors.
- Current use of clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin due to drug interactions with esomeprazole.
- Patients not receiving concomitant chemoradiotherapy or with esophageal dose less than 30 Gy (EQD2).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of thoracic radiation therapy plus 2 weeks after completion
Participants receive 40 mg of esomeprazole once daily before breakfast during thoracic radiation therapy and for two weeks after completing radiation therapy.
Visits scheduled according to radiation therapy and chemotherapy treatments
Duration - Up to 3 months from start of radiation therapy
Participants are monitored for symptoms of radiation induced esophagitis up to 3 months after starting radiation therapy.
Visits at 2 weeks after radiation therapy completion and at 3 months from radiation therapy start
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
S
Soumyajit Roy, MD, MSc.(c)
G
Gaurav Marwaha, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here