en Oncology Oncology Original Article Original Article <p style="margin: 0px 0px 13.33px; text-align: justify; line-height: 200%;"><span style="font-size:14px;"><span style="font-family:Times New Roman;"><em><span style="color:#0000ff;"><strong>Background:</strong></span></em> 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.<br> <em><span style="color:#0000ff;"><strong>Methods:</strong> </span></em>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.&nbsp; The influence of symptoms on lifestyle were also recorded weekly.<br> <em><span style="color:#0000ff;"><strong>Results:</strong></span></em> 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).<br> <em><span style="color:#0000ff;"><strong>Conclusion:</strong></span></em> This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.</span></span></p> Key words: Radiotherapy, Sucralfate, Acute Proctitis, Pelvic, Ointment 410 418 http://caspjim.com/browse.php?a_code=A-10-1476-2&slc_lang=en&sid=1 Sara Saei s.saei90@gmail.com 100319475328460024930 100319475328460024930 No Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran Adeleh Sahebnasagh masoomehsahebnasagh@gmail.com 100319475328460024931 100319475328460024931 No Department of Surgical Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran Arash Ghasemi dr_arash_ghasemi@yahoo.com 100319475328460024932 100319475328460024932 No Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran Jafar Akbari jafakbari@gmail.com 100319475328460024933 100319475328460024933 No Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran Ali Yaghobi Joybari Ali_Yaghobi_Joybari@yahoo.com 100319475328460024934 100319475328460024934 No Buali Hospital, Tehran Medical Sciences Branch, Islamic Azad University,Tehran, Iran Farid Nejad Dadgar fariddadgar2017@yahoo.com 100319475328460024935 100319475328460024935 No Buali Hospital, Tehran Medical Sciences Branch, Islamic Azad University,Tehran, Iran Shahram Ala sh204ala@yahoo.com 100319475328460024936 100319475328460024936 No Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran Ebrahim Salehifar salehifare@yahoo.com 100319475328460024937 100319475328460024937 Yes Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran Abbas Alipour alipour.abbas59@gmail.com 100319475328460024938 100319475328460024938 No Faculty of Medicine, Community medicine department, Mazandaran University of Medical Sciences, Sari, Iran