Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

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.

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).

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