NCT05659576

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Embedded Randomized Study to Assess Two-Stage Consent Design: There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control. The will first approach patients and explain that we are comparing different methods of informing patients about trials. If the patients do not wish to participate in the consent trial, participants will be approached for consent onto the therapeutic trial using the twostage research consent. Patients who decline or who are not approached to take part in the randomized compression of consent methods based on physician discretion, may still take part in the randomized comparison of sucralfate vs. control (therapeutic trial).

Conditions

• Radiation Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-12-21
• Last updated: 2026-01-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study