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Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

NCT05659576 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-01-27

No results posted yet for this study

Summary

The purpose of the study is to explore options for preventing and reducing symptoms of radiation esophagitis (RE). The researchers will also look what symptoms participants experience, and whether there are differences in weight loss in participants.

Conditions

  • Radiation Esophagitis

Interventions

DRUG

Sucralfate

1. Sucralfate, 1 gram/10 mL oral suspension "By mouth, take 10 mL twice a day until RT completion, with one dose 30-60 minutes prior to their midday meal and the second dose prior to bedtime".May increase frequency up to 4 times per day, per physician discretion". Or 2. Sucralfate 1 gram tablets By mouth, take one (1) tablet mixed in 15-30 mL warm water twice a day until RT completion, with one dose 30-60 minutes prior to their midday meal and the second dose prior to bedtime". The frequency of sucralfate can be adjusted at anytime at the treating physician's discretion after the patient has started it at twice a day, and the patient may discontinue sucralfate at anytime after RT completion, per physician discretion. May increase frequency up to 4 times per day, per physician discretion".

OTHER

Usual Care

Standard supportive care by using opioids.

OTHER

One consent

Patient will sign one consent form.

OTHER

Two consent

Patient will sign two consent forms.

Sponsors & Collaborators

Principal Investigators

  • Jacob Shin, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659576 on ClinicalTrials.gov