International journal of radiation oncology, biology, physics
-
Int. J. Radiat. Oncol. Biol. Phys. · Dec 2005
Randomized Controlled TrialPrevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients.
A common complication of pelvic radiotherapy (RT) is acute radiation-induced proctosigmoiditis (RIPS), for which a multitude of therapies have been tried. The 5-aminosalicylates (5-ASA), which are traditionally used to treat inflammatory bowel disease, have been tested; however, all but one prior randomized attempt to limit or prevent RIPS with 5-ASA-type agents have failed. We sought to evaluate balsalazide, a new 5-ASA drug, for its potential to prevent or limit RIPS in patients undergoing RT for carcinoma of the prostate, as a representative sample of pelvic RT patients. Balsalazide has a unique delivery system in that 99% of ingested drug is delivered to and activated in the colon, a higher yield than all other oral agents currently available in this class. Furthermore, it lacks the antigenic sulfa moiety present in sulfasalazine, the only other 5-ASA with demonstrated benefit in this setting. Thus, it was deemed an ideal candidate for preventing or limiting RIPS. ⋯ 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.
-
Int. J. Radiat. Oncol. Biol. Phys. · Dec 2005
Randomized Controlled TrialA phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer.
Acute radiation proctitis is the most relevant complication of pelvic radiation and is still mainly treated supportively. Considering the negative impact of acute proctitis symptoms on patients' daily activities and the potential relationship between the severity of acute radiation injury and late damage, misoprostol was tested in the prevention of acute radiation-induced proctitis. ⋯ Misoprostol given as a once-daily suppository did not decrease the incidence and severity of radiation-induced acute proctitis and may increase the incidence of acute bleeding.