Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Sucralfate

Criteria

Inclusion Criteria:

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

Esophageal dose:

• V50 ≥ 15% (25-35 fractions)

• V40 ≥ 15% (15-24 fractions)

• V30 ≥ 15% (10-14 fractions)

• Age 18 years of age or older.

Exclusion Criteria:

• No contraindication to sucralfate including inability to take sucralfate, either due to an allergy or the inability to swallow pills or liquid, being pregnant or nursing, actively taking drugs that have documented interactions with sucralfate such as cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and/or theophylline, diagnosis of chronic renal failure requiring dialysis, delayed gastric emptying or gastric bezoar

• PEG tube

• Actively taking any opioid pain medications prior to radiation therapy

• History of an opioid use disorder