alpha-chymotrypsin and Stomatitis

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

Based on in vitro and on clinical evidence of protection against acute side effects of radiation, a prospective randomized, open study was performed to determine the efficacy of an oral proteolytic enzyme preparation in patients with head and neck cancer receiving conventional fractionated radiation therapy.. Patients with stage T3/T4 head and neck cancer were eligible. One hundred patients from two centres were entered into the study. 60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in 25-35 fractions over a period of 6-7 weeks. Two lateral parallel opposing fields were used with a portal area of 10 x 15 cm. Patients assigned to the test group arm additionally received enzyme tablets orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5 days after completion of the course of radiation therapy. Patients in the control arm were not given any drug or placebo. Acute radiation side effects were described as mucositis, skin reaction, dysphagia, and were graded at each visit during and after radiation therapy, following RTOG/EORTC criteria.. The severity (maximum extent) of acute radiation therapy side effects was significantly less in enzyme-treated patients than in control patients: mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P < 0.001) and dysphagia (1.4 vs 2.2, P < 0.001). The duration of these side effects as well as the sum scores of side effects were also less in the study arm.. Combination of enzyme therapy with conventional fractionated radiation therapy was feasible and well-tolerated. There was significant protection against acute side effects of radiation therapy in the study arm. Not only was the severity of acute side effects less but the duration was shorter and the time to onset was also delayed. Prospective randomized double-blind studies would verify this role of an oral enzyme therapy as standard co-medication with radiation therapy to the head and neck region.

Topics: Acute Disease; Carcinoma, Squamous Cell; Chymotrypsin; Deglutition Disorders; Drug Combinations; Endopeptidases; Head and Neck Neoplasms; Humans; Male; Middle Aged; Papain; Prospective Studies; Radiation Injuries; Radiation-Protective Agents; Radiotherapy; Skin; Stomatitis; Trypsin

Topics: Administration, Topical; Anti-Inflammatory Agents; Chymotrypsin; Humans; Mouth Diseases; Neomycin; Occlusive Dressings; Ointments; Prednisolone; Stomatitis; Trypsin

Topics: Adolescent; Child; Chymotrypsin; Ear; Edema; Geriatrics; Humans; Injections, Intramuscular; Laryngitis; Otitis Media; Otolaryngology; Pharyngitis; Sinusitis; Stomatitis

Topics: Animals; Birds; Chymotrypsin; Hematologic Tests; Heparin; Humans; Inflammation; Pharyngitis; Stomatitis