Prophylactic Versus Therapeutic Sucralfate in Patients at High Risk for Radiation Esophagitis: Randomized Controlled Trial.

Abstract

We hypothesized that, in patients at high risk for radiation esophagitis (RE), giving sucralfate prophylactically would reduce the need for opioid pain medication. Patients were enrolled from January 2023 to April 2025 at a single tertiary care center. Patients were randomized to receive 1 g twice a day within the first 5 fractions of radiation therapy (RT), with frequency increased during RT at the clinician's discretion, or standard supportive care. The proportion of patients who took any opioids over the previous 24 hours at the end of the treatment course was compared between groups using logistic regression with the stratification variables and concurrent chemotherapy status as covariates. The trial was closed early due to lack of differences between arms, with 117 patients randomized (n = 56 in the experimental arm). Rates of opioid use were 30% in both groups (absolute adjusted decrease in the prophylactic sucralfate arm -0.4%; 95% CI, -14% to 13%, P > .9). Rates of grade 2 to 3 RE were nonsignificantly lower in the prophylactic sucralfate arm (59% vs 69%, absolute adjusted risk decrease 11%; 95% CI, -7.2% to 28%; P = .2). In patients receiving very high esophageal dose (V60 Gy ≥15%), all controls (n = 4) experienced grade 2 to 3 RE compared with only half of those in the experimental arm (6 of 12) (Fisher's exact test P = .2). We did not find evidence to support early use of sucralfate in patients at high risk of RE. Limited medical options for the management of RE warrant the continued need to explore further avenues to combat this painful condition.