title: Randomised clinical trial: preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer.
abstract: BACKGROUND
  Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy.
  
  
  OBJECTIVE
  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 3mg BDP enema or identical-looking PL during radiotherapy and, subsequently, two 3mg BDP suppositories or PL for 4 more weeks. Clinical and endoscopic evaluations before, 3 and 12months 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 12months. 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.
authors.affiliation: Department of Clinical Medicine, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. lorenzofuccio@gmail.com
authors.forename: L
authors.initials: L
authors.lastname: Fuccio
authors.forename: A
authors.initials: A
authors.lastname: Guido
authors.forename: L
authors.initials: L
authors.lastname: Laterza
authors.forename: L H
authors.initials: LH
authors.lastname: Eusebi
authors.forename: L
authors.initials: L
authors.lastname: Busutti
authors.forename: F
authors.initials: F
authors.lastname: Bunkheila
authors.forename: E
authors.initials: E
authors.lastname: Barbieri
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
mesh_terms: D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006801:Humans; D007558:Italy; D008297:Male; D016017:Odds Ratio; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D012002:Rectal Diseases / Q000517:prevention & control*; D012007:Rectum / Q000528:radiation effects; D013488:Suppositories; D016896:Treatment Outcome; D044465:White People
chemical_list: D000893:Anti-Inflammatory Agents; D013488:Suppositories; D001507:Beclomethasone