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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
Esophageal dose: V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily [BID] fractions)
Esophageal dose: V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily [BID] fractions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will investigate ways to prevent and reduce radiation esophagitis symptoms, and look at their impact on weight loss.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My esophageal radiation dose is within the specified range.
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My esophagus radiation dose is within the specified range.
Select...
I am 18 years old or older.
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My esophagus has been exposed to a certain level of radiation.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,355 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards could result from the Two Stage Consent process?

"Bearing in mind that this is a Phase 2 trial, our team at Power appraised the safety of Two Stage Consent as a score of two due to the presence of data confirming its security yet lacking evidence for efficacy."

Answered by AI

How many participants are registered for this medical trial?

"Verified. Clinicaltrials.gov confirms that this investigation, which was established on December 13th 2022, is currently accepting applicants. Approximately 352 participants need to be enrolled from 7 research sites."

Answered by AI

Are there any vacancies left for individuals to partake in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical study is actively welcoming participants who fulfill the criteria for enrolment. The trial was first posted on December 13th 2022 and has been recently updated with no changes as of that same date; 352 patients are being sought from 7 different sites across the country."

Answered by AI

In what locations can participants access this trial?

"Patients are being recruited for this clinical trial at the Memorial Sloan Kettering Monmouth (All Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (All Protocol Activities) in Montvale, and Memorial Sloan Kettering Suffolk-Commack (All Protocol Activites) in Commack as well as 7 other sites."

Answered by AI
~201 spots leftby Dec 2025