What side effects are associated with this type of intervention?

Common treatments for esophagitis include proton pump inhibitors (PPIs), mucosal protectants like sucralfate, and cytoprotective agents such as Amifostine. PPIs can cause side effects like headache, diarrhea, constipation, and abdominal pain. Sucralfate is generally well-tolerated but may cause constipation and dry mouth. Amifostine, used for its cytoprotective properties, can lead to side effects such as nausea, vomiting, hypotension, and allergic reactions. These treatments aim to reduce inflammation and protect the esophageal lining, but patients should discuss potential side effects with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved various treatments for esophagitis, including proton pump inhibitors (PPIs) and H2 receptor antagonists, which reduce stomach acid and help heal the esophagus. While the provided context does not mention specific FDA approvals for cytoprotective agents like Amifostine for esophagitis, it does highlight the use of trimoprostil, a prostaglandin E2 analog with cytoprotective properties, in studies related to esophageal conditions. Additionally, Mitomycin C has shown promise in treating refractory esophageal strictures, though further studies are needed to establish its efficacy and safety.

What other types of research exist?

Promising novel alternatives to Amifostine for esophagitis patients include radiofrequency energy delivery (Stretta) and transoral incisionless fundoplication (EsophyX). These treatments are actively being tried and may offer new options for managing esophagitis.

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Sucralfate for Esophagitis

Phase 2

Recruiting

Led By Jacob Shin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial is testing sucralfate, a medication that protects the esophagus, to see if it can prevent or reduce symptoms of radiation esophagitis. The study focuses on patients undergoing radiation therapy who are at risk of developing this painful condition. Sucralfate works by coating the esophagus to shield it from damage. Sucralfate has been evaluated for its protective adherence to denuded surfaces and bile salt-binding properties, showing efficacy in treating reflux esophagitis.

Who is the study for?

This trial is for adults over 18 who are undergoing thoracic irradiation and have a high risk of developing esophagitis due to their treatment. It's not for those with feeding tubes, current opioid use, known issues taking Sucralfate, or a history of opioid addiction.

What is being tested?

The study tests if Sucralfate can prevent or reduce radiation esophagitis symptoms compared to usual care during thoracic irradiation. Researchers will monitor symptom differences and weight loss among participants.

What are the potential side effects?

Sucralfate may cause side effects like constipation, dry mouth, upset stomach, rash or itching. Usual care side effects depend on the standard treatments given alongside radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accrual rate (Two-stage consent part)

Reduce opioid use

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Two Stage ConsentExperimental Treatment1 Intervention

Patient will sign two consent forms.

Group II: SucralfateExperimental Treatment1 Intervention

During their RT course, patients randomized to the PS arm will receive a prescription for either: 1) sucralfate, 1 gram/10 mL oral suspension or 2) sucralfate 1 gram tablets.

Group III: One Stage ConsentActive Control1 Intervention

Patient will sign one consent form.

Group IV: Usual CareActive Control1 Intervention

Standard supportive care by using opioids.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sucralfate

2003

Completed Phase 4

~580

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for esophagitis include proton pump inhibitors (PPIs) and H2 receptor antagonists, which reduce gastric acid production to minimize acid-induced esophageal damage. Cytoprotective agents like amifostine work by scavenging free radicals and enhancing tissue repair, particularly useful in radiation-induced esophagitis. These mechanisms are important for esophagitis patients as they help in selecting treatments that effectively alleviate symptoms and promote healing of the esophageal tissue.

Effects of acute administration of a prostaglandin E2 analog, trimoprostil, on esophageal motility in man.Corrosive esophageal injuries. II. An investigation of treatment methods and histochemical analysis of esophageal strictures in a new animal model.Effects of Pyridostigmine on Esophageal and Pharyngeal Motility in Dysphagic Patients Undergoing High-Resolution Manometry.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,204 Total Patients Enrolled

Jacob Shin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

29 Total Patients Enrolled

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT05659576 — Phase 2

Esophagitis Research Study Groups: One Stage Consent, Two Stage Consent, Sucralfate, Usual Care

Esophagitis Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT05659576 — Phase 2

Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659576 — Phase 2

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