Efficacy of Wobe-Mugos E for reduction of oral mucositis after radiotherapy : results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study.
OBJECTIVE
To investigate the efficacy and safety of Wobe-Mugos E (proteolytic enzymes) for amelioration of early side effects of radiotherapy for head-and-neck tumors, particularly oral mucositis.


METHODS
The study was a prospective, randomized, multicenter, placebo-controlled, triple-blind phase III study with parallel groups. 69 patients with carcinomas of the oropharynx or the oral cavity were enrolled between 1996 and 2000 in five centers; 54 of these were recruited in Dresden. Of the 69 patients, 61 (Dresden: 46) were available for analysis. The proteolytic enzymes tested (Wobe-Mugos E) comprised papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg.


RESULTS
Wobe-Mugos E was well tolerated. For the maximum mucositis scores, no statistically significant differences were found between the placebo and the verum group. The average mucositis score over weeks 1-6 revealed a significant difference in favor of the placebo arm, based on an earlier onset of mucositis in the Wobe-Mugos E group.


CONCLUSIONS
The present study failed to demonstrate any effect of treatment with Wobe-Mugos E on radiotherapy side effects in patients treated for head-and-neck tumors. In particular, there was no beneficial effect on radiation-induced early oral mucositis.
Dörr
Wolfgang
W
Department of Radiotherapy and Radiooncology, Medical Faculty Carl Gustav Carus, University of Technology, Dresden, Germany. doerr@rcs.urz.tu-dresden.de
Herrmann
Thomas
T
D000328:Adult; D000368:Aged; D002918:Chymotrypsin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D009062:Mouth Neoplasms / Q000532:radiotherapy*; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D010206:Papain / Q000627:therapeutic use*; D011446:Prospective Studies; D011832:Radiation Injuries / Q000188:drug therapy*; D018714:Radiotherapy, Adjuvant; D013280:Stomatitis / Q000188:drug therapy*; D017211:Treatment Failure; D014357:Trypsin / Q000627:therapeutic use*
D004338:Drug Combinations; C009685:chymotrypsin, papain, trypsin drug combination; D002918:Chymotrypsin; D014357:Trypsin; D010206:Papain