Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Conditions
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Radiation Esophagitis

Intervention / Treatment
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* Drug: Sucralfate
* Other: Usual Care
* Other: One consent
* Other: Two consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm randomized study. There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One Stage Consent<br>Patient will sign one consent form. | Other: One consent<br>* Patient will sign one consent form.<br>|
| Experimental: Two Stage Consent<br>Patient will sign two consent forms. | Other: Two consent<br>* Patient will sign two consent forms.<br>|
| Experimental: Sucralfate<br>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. | Drug: Sucralfate<br>* 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 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.<br>|
| Active Comparator: Usual Care<br>Standard supportive care by using opioids. | Other: Usual Care<br>* Standard supportive care by using opioids.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal, Sucralfate, Radiation Therapy, Thoracic cancer, 22-307