48 Participants Needed

Esomeprazole for Esophagitis

(EERENs Trial)

SR
GM
SR
Overseen BySoumyajit Roy, MD, MSc.(c)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

If you are currently taking clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin, you will need to stop these medications as they may interact with esomeprazole.

Is esomeprazole generally safe for human use?

Esomeprazole is generally well-tolerated in humans, with side effects similar to those of omeprazole, another common medication for acid-related disorders. Clinical trials have shown it to be safe for use in treating conditions like gastroesophageal reflux disease and erosive esophagitis.12345

How is the drug esomeprazole different from other treatments for esophagitis?

Esomeprazole is unique because it is the S-isomer of omeprazole, providing better control of stomach acid and more effective healing of erosive esophagitis compared to other proton pump inhibitors like omeprazole and lansoprazole. It also has an improved pharmacokinetic profile, meaning it is absorbed and processed by the body more consistently, leading to more reliable results.13678

What data supports the effectiveness of the drug Esomeprazole for treating esophagitis?

A study showed that esomeprazole is effective in healing severe forms of reflux esophagitis (a condition where the esophagus becomes inflamed due to acid reflux) over a 6-month period, especially in patients with certain genetic factors.910111213

Who Is on the Research Team?

SM

Soumyajit M Roy, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage III non-small cell lung cancer (NSCLC) who are about to receive thoracic radiation and chemotherapy. They must be able to consent, follow the visit schedule, and have an ECOG score of 0-2. Women who can bear children need a negative pregnancy test. Participation in another trial may be okay if allowed.

Inclusion Criteria

Double inclusion in any ongoing trial (if the other trial permits) will be allowed
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
See 4 more

Exclusion Criteria

Patient has known or suspected allergic response and prior adverse drug reaction with proton pump inhibitors
I have inflammation in my kidneys.
I have had cancer in my stomach or where my esophagus meets my stomach.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thoracic radiation therapy with concomitant chemotherapy and esomeprazole 40 mg daily

Duration of TRT (typically 6-7 weeks)
Weekly visits for radiation therapy

Post-Treatment

Participants continue esomeprazole for 2 weeks after completion of thoracic radiation therapy

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months from the start of TRT
Visits at 2 weeks post-TRT and 3 months from start of TRT

What Are the Treatments Tested in This Trial?

Interventions

  • Esomeprazole
Trial Overview The study tests whether Esomeprazole 40 mg can prevent or reduce esophagitis caused by radiation therapy in NSCLC patients receiving combined chemo (and possibly immunotherapy).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Published Research Related to This Trial

In a study of 113 patients with reflux esophagitis grades C and D, esomeprazole 40 mg daily for 6 months was effective in promoting healing, regardless of the patients' CYP2C19 genotypes.
A higher body mass index (BMI) over 25 kg/mยฒ was linked to lower healing rates, while reducing BMI by more than 1.5 kg/mยฒ significantly improved healing outcomes, suggesting weight management could enhance treatment efficacy.
Body mass index can determine the healing of reflux esophagitis with Los Angeles Grades C and D by esomeprazole.Sheu, BS., Chang, WL., Cheng, HC., et al.[2014]
In a study of 188 patients with acromegaly, factors such as IGF-I levels, weight, height, and age were found to significantly predict the optimal dose of pegvisomant (PEGV) needed to normalize IGF-I levels when used alongside long-acting somatostatin analogues (LA-SSAs).
For patients receiving PEGV as monotherapy, only weight was a significant predictor of the required dose, indicating that dosing strategies may need to be tailored based on individual patient characteristics.
A multivariable prediction model for pegvisomant dosing: monotherapy and in combination with long-acting somatostatin analogues.Franck, SE., Korevaar, TIM., Petrossians, P., et al.[2019]
Pegvisomant was found to be significantly more effective than octreotide in suppressing the growth hormone (GH) axis, achieving up to 62% suppression of total IGF-I levels after 14 days of treatment in 80 healthy subjects.
The safety profile of pegvisomant was favorable, with most adverse events being mild (grade 1 or 2), including injection site reactions, headache, and fatigue, suggesting it could be a viable option for treating GH-dependent tumors.
Clinical pharmacodynamic effects of the growth hormone receptor antagonist pegvisomant: implications for cancer therapy.Yin, D., Vreeland, F., Schaaf, LJ., et al.[2016]

Citations

Body mass index can determine the healing of reflux esophagitis with Los Angeles Grades C and D by esomeprazole. [2014]
A multivariable prediction model for pegvisomant dosing: monotherapy and in combination with long-acting somatostatin analogues. [2019]
Clinical pharmacodynamic effects of the growth hormone receptor antagonist pegvisomant: implications for cancer therapy. [2016]
Combined treatment for acromegaly with long-acting somatostatin analogs and pegvisomant: long-term safety for up to 4.5 years (median 2.2 years) of follow-up in 86 patients. [2016]
Might adrenergic alpha2C-agonists/alpha2A-antagonists become novel therapeutic tools for pain treatment with morphine? [2013]
Physical and chemical stability of esomeprazole sodium solutions. [2022]
[Efficiency and safety of the intravenous application of esomeprazole (nexium - Astra Zeneca) in high risk patients subjected to mechanic ventilation]. [2018]
Review of esomeprazole in the treatment of acid disorders. [2019]
Efficacy of esomeprazole in patients with acid-peptic disorders. [2019]
[Long-term treatment of patients with symptomatic gastroesophageal reflux disease comparing costs and efficacy over 6 months of treatment with Nexium On-Demand Treatment or Nexium continuous treatment. An open, randomised multi-center study]. [2013]
Systematic review of proton pump inhibitors for the acute treatment of reflux oesophagitis. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Esomeprazole magnesium (Nexium). [2013]
Cost effectiveness of esomeprazole compared with omeprazole in the acute treatment of patients with reflux oesophagitis in the UK. [2018]
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