Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2026-12-31

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.

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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 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

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Radiation Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One Stage Consent

Patient will sign one consent form.

Group Type ACTIVE_COMPARATOR

One consent

Intervention Type OTHER

Patient will sign one consent form.

Two Stage Consent

Patient will sign two consent forms.

Group Type EXPERIMENTAL

Two consent

Intervention Type OTHER

Patient will sign two consent forms.

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.

Group Type EXPERIMENTAL

Sucralfate

Intervention Type DRUG

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".

Usual Care

Standard supportive care by using opioids.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Standard supportive care by using opioids.

Interventions

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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".

Intervention Type DRUG

Usual Care

Standard supportive care by using opioids.

Intervention Type OTHER

One consent

Patient will sign one consent form.

Intervention Type OTHER

Two consent

Patient will sign two consent forms.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No