Majallah-i Dānishgāh-i ̒Ulūm-i Pizishkī-i Bābul (Aug 2009)
The Effect of Sucralfate in Prevention of Radiation- Induced Acute Proctitis
Abstract
BACKGROUND AND OBJECTIVE: Acute proctitis is a common, disturbing side effect of pelvic irradiation that might interrupt treatment. To decrease or prevention of these side effects many drugs were used but no effective treatment was found. The aim of this study was to evaluate the efficacy of sucralfate for possible reduction of radiation-induced lower GI toxicities.METHODS: In this clinical trial study 100 patients that required curative pelvic radiation therapy were randomly divided into two groups. Group one received 3g oral sucralfate and group two received placebo as control. All patients were given at least 50 Gy external-beam irradiation. Their bowel symptoms that include diarrhea, abdominal pain or distention, mucous or bloody discharge, obstruction or perforation were scored according to the RTOG/EORTC acute toxicity criteria. Desquamation and duration of treatment interruption were studied in both groups.FINDINGS: From cases, there were 49 cases in group one and 47 cases in group two and 4 cases were excluded from study. The two groups were statistically the same according to sex, age, anatomopathology and radiation therapy parameters. Comparing acute lower GI toxicities, desquamation and duration of treatment interruption, there were no statistically significant differences between the two groups. No acute lower GI toxicities were seen in 18 cases from group one and 10 cases from group two. No grade 4 lower GI toxicities were seen in patients.CONCLUSION: In our study, there was no clinical evidence that oral sucralfate ameliorates radiation-induced proctitis. Therefore, sucralfate as a routine prophylactic agent is not suggested in pelvic radiation therapy and further investigations are generally needed to find out the efficacy of sucralfate in radiation-induced GI toxicities.
