RecruitingPhase 2NCT06120803

Esomeprazole and Radiation Induced Esophagitis

Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study


Sponsor

Rush University Medical Center

Enrollment

48 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether the heartburn drug esomeprazole (a proton pump inhibitor, commonly used to reduce stomach acid) can help prevent or reduce the painful throat inflammation (esophagitis) that often develops when people with lung cancer receive radiation to the chest along with chemotherapy. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with stage III non-small cell lung cancer (NSCLC) - You are about to receive chest radiation (at least 30 Gy to the esophagus) combined with chemotherapy - You are in reasonable overall health (ECOG 0–2) **You may NOT be eligible if...** - You have a history of stomach or esophageal junction cancer - You have a history of peptic ulcer disease or prior upper gastrointestinal bleeding - You have severe pre-existing difficulty swallowing - You have severe liver disease or kidney inflammation (interstitial nephritis) - You are currently taking certain medications that interact with esomeprazole (including clopidogrel, nelfinavir, rilpivirine, or phenytoin) - You have had chest radiation in the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsomeprazole 40 mg

Enrolled patients will receive 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily before breakfast for the entire duration of TRT (including the weekends and any interim gap period) and for two weeks after completion of thoracic radiation therapy.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT06120803


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