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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at esomeprazole and swelling or irritation in the food pipe caused by radiation. It is for adults with stage III non-small cell lung cancer who will get chest radiation and chemotherapy at the same time.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- You or your legal representative can sign consent and health privacy forms before any study activities.
- You can follow the planned visit and treatment schedules.
- A tissue test confirms stage III non-small cell lung cancer.
- You will get chest radiation and chemotherapy at the same time. The highest planned radiation dose to your food pipe must be at least 30 Gy (EQD2, a measure of radiation dose).
- Your activity score (ECOG) is 0 to 2: you can care for yourself and are up for more than half the day.
- If you could become pregnant, you must have a negative pregnancy test within 2 weeks before joining.
- You may also join another ongoing trial if that trial allows it.
Who can't join
- You have had cancer of the stomach or where the food pipe meets the stomach.
- You already have severe or very severe trouble swallowing.
- You have had severe liver disease or acute or subacute lupus, an illness in which the immune system attacks the body.
- You have interstitial nephritis, a type of kidney inflammation.
- You have had peptic ulcers (sores in the stomach or upper intestine) or bleeding in the upper digestive tract.
- You had chest radiation within 2 years before joining.
- You have a known or suspected allergy, or a past bad drug reaction, to proton pump inhibitors, a type of acid-reducing medicine.
- You take clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin. These medicines may have major interactions with esomeprazole.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
IL
- Rush University Medical Center · Chicago, IL 60612Soumyajit Roy, MD · Study contact · 312-942-5655 · soumyajit_roy@rush.eduMore trials in Chicago