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Completed
NCT05659576
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
Conditions: Radiation Esophagitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 142
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities) Basking Ridge New Jersey
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05659576). StuddyBuddy aggregates publicly available trial information.