title: Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer: A double-blind, randomized trial.
abstract: OBJECTIVE
  To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy.
  
  
  METHODS
  A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment.
  
  
  RESULTS
  A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the sucralfate arm (p = 0.23; 95% confidence interval for the difference -3% to 16%). Seventeen percent of patients in the sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group (p = 0.18, 95% confidence interval -15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency (p = 0.99), mucus discharge (p = 0.64), or fecal incontinence (p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the sucralfate group (p = 0.25).
  
  
  CONCLUSIONS
  This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.
authors.affiliation: Cancer Therapy Centre, Liverpool Hospital, Liverpool, Australia. Andrew.Kneebone@swsahs.nsw.gov.au
authors.forename: Andrew
authors.initials: A
authors.lastname: Kneebone
authors.forename: Hedy
authors.initials: H
authors.lastname: Mameghan
authors.forename: Terry
authors.initials: T
authors.lastname: Bolin
authors.forename: Martin
authors.initials: M
authors.lastname: Berry
authors.forename: Sandra
authors.initials: S
authors.lastname: Turner
authors.forename: John
authors.initials: J
authors.lastname: Kearsley
authors.forename: Peter
authors.initials: P
authors.lastname: Graham
authors.forename: Richard
authors.initials: R
authors.lastname: Fisher
authors.forename: Geoff
authors.initials: G
authors.lastname: Delaney
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000175:diagnosis / Q000188:drug therapy*; D012007:Rectum / Q000528:radiation effects*; D012812:Sigmoidoscopy; D013392:Sucralfate / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D013392:Sucralfate