Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer: A double-blind, randomized trial

Andrew Kneebone*, Hedy Mameghan, Terry Bolin, Martin Berry, Sandra Turner, John Kearsley, Peter Graham, Richard Fisher, Geoff Delaney

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    36 Citations (Scopus)


    Purpose To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy. Methods and materials 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). Conclusion 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.

    Original languageEnglish
    Pages (from-to)1088-1097
    Number of pages10
    JournalInternational Journal of Radiation Oncology, Biology, Physics
    Issue number4
    Publication statusPublished - 15 Nov 2004


    • Prostate cancer
    • Radiotherapy
    • Rectal injury
    • Sucralfate


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