Efficacy of Sucralfate Ointment in Prevention of Acute Proctitis in Cancer Patients: a Randomized Controlled Clinical Trial

Background: Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis. Methods: Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency.  The influence of symptoms on lifestyle were also recorded weekly. Results: Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P= 0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) were significantly less common in the sucralfate group. No statistically significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27). Conclusion: This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.