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

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

This study is testing if the medication esomeprazole can help lung cancer patients undergoing radiation therapy avoid painful throat problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rush University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation, methotrexate, immunotherapy
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06120803 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of stage III non-small cell lung cancer receiving thoracic radiation therapy.

Not a fit: Patients with a history of gastroesophageal junction issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the management of radiation-induced esophagitis, enhancing the quality of life for lung cancer patients undergoing treatment.

How similar studies have performed: While anecdotal evidence suggests potential benefits of proton pump inhibitors for this condition, robust prospective studies specifically targeting esomeprazole's effectiveness in radiation-induced esophagitis are limited, making this approach relatively novel.

Eligibility criteria

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 this trial is running

Chicago, Illinois

• 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)

Conditions Radiation Esophagitis; Locally Advanced Lung Carcinoma