Using esomeprazole to reduce radiation-induced esophagitis in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of esomeprazole, a proton pump inhibitor, in reducing the incidence of symptomatic radiation-induced esophagitis in patients undergoing thoracic radiation therapy for locally advanced non-small cell lung cancer (NSCLC). The study aims to provide robust evidence for the use of esomeprazole, which has shown potential antioxidant and anti-inflammatory properties, to improve patient quality of life and minimize treatment interruptions. Participants will receive esomeprazole 40 mg alongside their standard treatment regimen. The trial will assess the frequency of grade ≥2 esophagitis symptoms compared to historical data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is ≥ 18 years of age.
* Patient or patient's legal representative is willing and able to provide written informed consent and HIPAA authorization prior to performance of any study related activity.
* Patient is willing and able to comply with scheduled visits and treatment schedules.
* Patient has histopathologically confirmed diagnosis of NSCLC clinical stage III (as per the 8th edition of American Joint Committee on Cancer Staging).
* Patients will receive thoracic radiation with estimated maximum dose to esophagus of at least 30 Gy (EQD2) in combination with concomitant chemotherapy.
* Patient has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine HCG) within 2 weeks of enrollment).
* Double inclusion in any ongoing trial (if the other trial permits) will be allowed.

Exclusion Criteria:

* Patient has history of gastroesophageal junction or stomach cancer.
* Patient has history of pre-existing severe or very severe dysphagia.
* Patient has history of severe liver disease, acute or subacute systemic lupus erythematosus.
* Patient has interstitial nephritis.
* Patient has history of peptic ulcer disease.
* Patient has prior history of upper gastrointestinal bleeding.
* Patient has a history of thoracic radiotherapy within 2 years of enrollment.
* Patient has known or suspected allergic response and prior adverse drug reaction with proton pump inhibitors.
* Patient is currently on clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin as these may have major drug interaction with esomeprazole.
* Patients without concomitant chemoradiotherapy and with estimated maximum dose to esophagus of less than 30 Gy (EQD2).

Where it's running

• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Soumyajit M Roy, PhD — Rush University Medical Center
• Study coordinator: Soumyajit Roy, MD, MSc.(c)
• Email: soumyajit_roy@rush.edu
• Phone: 312-942-5655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.