alpha-chymotrypsin and Mouth-Neoplasms

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.. 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.. 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.. 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.

Topics: Adult; Aged; Chymotrypsin; Combined Modality Therapy; Dose Fractionation, Radiation; Drug Combinations; Female; Humans; Male; Middle Aged; Mouth Mucosa; Mouth Neoplasms; Neoplasm Staging; Oropharyngeal Neoplasms; Papain; Prospective Studies; Radiation Injuries; Radiotherapy, Adjuvant; Stomatitis; Treatment Failure; Trypsin

Topics: Carbon Radioisotopes; Carcinoma; Cell Line; Cell Survival; Chymotrypsin; Diphtheria Antitoxin; Diphtheria Toxin; Kinetics; Mouth Neoplasms; Neoplasm Proteins; Phospholipases; Pronase; Protein Biosynthesis; Time Factors; Trypsin; Valine

Topics: Adenoviridae; Animals; Arginine; Carcinoma; Cell Line; Chymotrypsin; Culture Techniques; Cytopathogenic Effect, Viral; Humans; Hydrocarbons, Halogenated; Keratoconjunctivitis; Mouth Neoplasms; Mycoplasma; Rabbits; Ultracentrifugation; Virus Cultivation; Virus Replication