Efficacy of sucralfate ointment in the 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 was 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) was significantly less common in the sucralfate group. no statistical 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.