Prevention of acute radiation-induced proctosigmoiditis by balsalazide: A randomized, double-blind, placebo controlled trial in prostate cancer patients

Conclusions: Balsalazide is a new-generation 5-ASA drug that yields a high concentration of active drug to the distal colon. Results of this pilot study suggest that it is able to prevent or reduce symptoms of RIPS in patients undergoing RT for prostate cancer. We feel that these results justify the formation of a cooperative group trial to assess its efficacy in a multi-institutional setting.