Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Phase 2

Recruiting

• Conditions: Radiation Esophagitis
• Interventions: Other: Usual Care; Other: Two consent; Other: One consent; Drug: Sucralfate

• Registration Number: NCT05659576
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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 traditional onestage 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).

Study Timeline

• Study Start: 2022-12-13
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:

Esophageal dose:

• V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily [BID] fractions)

• V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily [BID] fractions)

• V30 ≥ 15% (10-14 once daily fractions)

  • Age 18 years of age or older.

Exclusion Criteria

• Known inability to take Sucralfate (tablet and/or suspension form), per physician discretion
• PEG tube
• Actively taking any opioid pain medications prior to radiation therapy
• History of an opioid use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Standard supportive care by using opioids.
Two Stage Consent	Two consent	Patient will sign two consent forms.
One Stage Consent	One consent	Patient will sign one consent form.
Sucralfate	Sucralfate	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.

Primary Outcome Measures

Name	Time	Method
Accrual rate (Two-stage consent part)	1 year	Determine accrual rate of two-stage consent compared to standard onestage consent.
Reduce opioid use	2 years	as measured by documented opioid use within the past 24 hours in the EMR at time of final weekly status check

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States