A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer.
OBJECTIVE
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.


METHODS
A total of 100 patients who underwent radiotherapy for prostate cancer were entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. Radiation-induced toxicity was evaluated weekly during radiotherapy using the Common Toxicity Criteria.


RESULTS
Between the placebo and the misoprostol groups, no significant differences in proctitis symptoms occurred: 76% of patients in each group had Grade 1 toxicity, and 26% in the placebo group and 36% in the misoprostol group had Grade 2 toxicity. No differences were found in onset or symptom duration. Comparing the peak incidence of patients' toxicity symptoms, significantly more patients experienced rectal bleeding in the misoprostol group (p = 0.03).


CONCLUSIONS
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.
Hille
Andrea
A
Department of Radiotherapy and Radiooncology, University of Goettingen, Goettingen, Germany. ahille@med.uni-goettingen.de
Schmidberger
Heinz
H
Hermann
Robert M
RM
Christiansen
Hans
H
Saile
Bernhard
B
Pradier
Olivier
O
Hess
Clemens F
CF
D000208:Acute Disease; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D016595:Misoprostol / Q000627:therapeutic use*; D011349:Proctitis / Q000209:etiology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D012007:Rectum / Q000528:radiation effects*; D018709:Statistics, Nonparametric; D013488:Suppositories
D000897:Anti-Ulcer Agents; D013488:Suppositories; D016595:Misoprostol