Gujral, M. S., Patnaik, P. M., Kaul, R., Parikh, H. K., Conradt, C., Tamhankar, C. P., & Daftary, G. V. (2001). Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers. Cancer Chemotherapy and Pharmacology, 47, S23–S28.

To determine the effect of oral proteolytic enzymes for prevention of acute side effects in patients with head and neck cancer.

Patients were randomly assigned to the control or experimental group.

The enzymes taken were a combination of papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg (MUCOS Pharma). Patients took three tablets, three times per day, three days prior to start of radiation therapy (RT), and up to five days after completion.

Mucositis, skin reaction, and dysphagia were graded at each visit during and after RT. Scoring was done at baseline, weekly, and five to six months following treatment.

• The sample was comprised of 98 men.
• Age ranged from 18 to 65 years.
• Patients had T3/T4 cancers of the head and neck region with squamous cell.
• Patients received Cobalt 60 gamma radiation at a standard daily dose of 2 Gy in 25 to 35 fractions over six to seven weeks. 
• Thirty-three patients were hospitalized to ensure compliance.

• Multisite
• Indore and Cuttack, India

The study was a prospective, randomized, open-label trial.

• Radiation Therapy Oncology Group (RTOG) criteria
• Compliance was monitored by counting pills.
• Grading was performed by the same person every time.
• Wilcoxon summed was used to test for differences.

• The average skin reaction score was lower in those treated with enzymes (p < 0.0001).
• The maximal extent of acute toxicity was lower in those who took enzymes.
• Two patients in the experimental group were dropped due to the most severe acute reactions.

Oral proteolytic enzymes may be helpful in reducing the severity of radiodermatitis.

• Slightly more than one-third of the patients had to be hospitalized to ensure compliance with treatment, which suggests the impracticality for clinical use in this population.
• Multiple patients had treatment delays, most of which were associated with social issues.
• Skin reactions per RT dose levels were not compared.