Dorr, W., & Herrmann, T. (2007). 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. Strahlentherapie und Onkologie, 183(3), 121–127.

Intervention Characteristics/Basic Study Process

Proteolytic enzymes comprised of papain (100 mg), trypsin (40 mg), and chymotrypsin (40 mg) were administered orally 3 x 4 tablets per day.

Sample Characteristics

The study reported on 69 patients with tumors of the oropharynx or oral cavity undergoing a radiation dose higher than 40 Gy.

Setting

The study was conducted at a multicenter site from June 1996 to May 2000.

Study Design

This was a prospective, randomized, triple-blind, placebo-controlled, parallel group study.

Measurement Instruments/Methods

  • Maximum grade of mucositis was recorded.
  • The Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria were used.

Results

No statistically significant difference was found in analysis. Treatment with Wobe-Mugos E resulted in an earlier onset of mucositis and increased average scores for treatment duration.

Limitations

The sample was not sufficient according to power analysis.