Randomised clinical trial: preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer

Background Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy. Aim To assess the effect of topical beclomethasone dipropionate (BDP) in the prevention of radiation-induced proctopathy in patients undergoing radiotherapy for prostate cancer through a double-blind, placebo-controlled, randomised trial. Methods Patients were randomised either to BDP or to placebo (PL). Patients received daily a 3 mg BDP enema or identical-looking PL during radiotherapy and, subsequently, two 3 mg BDP suppositories or PL for 4 more weeks. Clinical and endoscopic evaluations before, 3 and 12 months after the end of radiotherapy were assessed with the RTOG/EORTC toxicity scales, the modified Simple Clinical Colitis Activity Index (SCCAI), the modified Inflammatory Bowel disease Quality of Life Index (IBDQ) and the Vienna Rectoscopy Score (VRS). Results From June 2007 to October 2008, 120 patients were randomised to the BDP (n = 60) and PL (n = 60) arms and were followed up for 12 months. The overall assessment of rectal side effects did not show significant differences between the two groups of treatment. However, when only rectal bleeding was considered, a significantly reduced risk was observed in patients on BDP (OR 0.38; 95% CI 0.17-0.86; P = 0.02; NNT = 5). Patients on BDP had also significantly lower VRS scores (P = 0.028) and significantly higher IBDQ scores (P = 0.034). Conclusions Preventive treatment with topical rectal BDP during radiotherapy for prostate cancer significantly reduces the risk of rectal bleeding and radiation-induced mucosal changes and improves patient's quality of life, but does not influence other radiation-induced symptoms.