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

Abstract

Purpose: 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 and Materials: 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). Conclusion: 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.

Authors:
 [1];  [2];  [2];  [2];  [3];  [2];  [2]
  1. Department of Radiotherapy and Radiooncology, University of Goettingen, Goettingen (Germany). E-mail: ahille@med.uni-goettingen.de
  2. Department of Radiotherapy and Radiooncology, University of Goettingen, Goettingen (Germany)
  3. Department of Gastroenterology and Endocrinology, University of Goettingen, Goettingen (Germany)
Publication Date:
OSTI Identifier:
20788244
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 63; Journal Issue: 5; Other Information: DOI: 10.1016/j.ijrobp.2005.05.063; PII: S0360-3016(05)01121-1; Copyright (c) 2005 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; DAMAGE; PATIENTS; PROCTITIS; PROSTATE; RADIATION INJURIES; RADIOTHERAPY; SYMPTOMS; TOXICITY

Citation Formats

Hille, Andrea, Schmidberger, Heinz, Hermann, Robert M., Christiansen, Hans, Saile, Bernhard, Pradier, Olivier, and Hess, Clemens F. A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer. United States: N. p., 2005. Web. doi:10.1016/J.IJROBP.2005.0.
Hille, Andrea, Schmidberger, Heinz, Hermann, Robert M., Christiansen, Hans, Saile, Bernhard, Pradier, Olivier, & Hess, Clemens F. A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer. United States. doi:10.1016/J.IJROBP.2005.0.
Hille, Andrea, Schmidberger, Heinz, Hermann, Robert M., Christiansen, Hans, Saile, Bernhard, Pradier, Olivier, and Hess, Clemens F. Thu . "A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer". United States. doi:10.1016/J.IJROBP.2005.0.
@article{osti_20788244,
title = {A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer},
author = {Hille, Andrea and Schmidberger, Heinz and Hermann, Robert M. and Christiansen, Hans and Saile, Bernhard and Pradier, Olivier and Hess, Clemens F.},
abstractNote = {Purpose: 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 and Materials: 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). Conclusion: 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.},
doi = {10.1016/J.IJROBP.2005.0},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 63,
place = {United States},
year = {Thu Dec 01 00:00:00 EST 2005},
month = {Thu Dec 01 00:00:00 EST 2005}
}