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.

Abstract

PURPOSE:

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.

PATIENTS AND 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.

CONCLUSION:

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.

• Authors: Wolfgang Dörr, Thomas Herrmann, Study Group
• Journal: Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] (Strahlenther Onkol) Vol. 183 Issue 3 Pg. 121-7 (Mar 2007) ISSN: 0179-7158 [Print] Germany
• PMID: 17340069 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Combinations
• chymotrypsin, papain, trypsin drug combination
• Chymotrypsin
• Trypsin
• Papain

Topics

• Adult
• Aged
• Chymotrypsin (therapeutic use)
• Combined Modality Therapy
• Dose Fractionation, Radiation
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Mouth Mucosa (radiation effects)
• Mouth Neoplasms (radiotherapy)
• Neoplasm Staging
• Oropharyngeal Neoplasms (pathology, radiotherapy, surgery)
• Papain (therapeutic use)
• Prospective Studies
• Radiation Injuries (drug therapy)
• Radiotherapy, Adjuvant
• Stomatitis (drug therapy)
• Treatment Failure
• Trypsin (therapeutic use)