Oral enzymes preventing side effects of radiation therapy in patients with head and neck cancers

Gujral M.S. (1); Patnaik P.M. (2); Kaul R. (1); Daftary G.V. (3); Parikh H.K. (3); Tamhankar C.P. (3); Schiess W. (4)

1 SGPT Cancer Hospital, M.Y. Hospital Campus, Indore, India
2 AH Regional Cancer Centre, Cuttack, India
3 SIRO Research Foundation, Mumbai, India
4 MUCOS Pharma, Clinical Research, Geretsried, Germany

The European Cancer Conference, Vienna 12. -16. Sept. 1999, Enzyme forum ECCO 10, abs. 8
published in The European Journal of Cancer 1999; Vol. 35, Suppl. 4, poster 634, pp. 168-169.

599 KA (19-07-2)

Czech version

Based on in vitro data and on clinical evidence of a protective action against acute side effects of radiotherapy, a prospective randomised study was undertaken to determine the safety and efficacy of an oral enzyme combination in patients with head and neck cancer receiving conventional fractionated radiotherapy (Wobe-Mugos® E, MUCOS Pharma, Geretsried, Germany) (OE). Two study centres included 100 patients with locally advanced head and neck cancer into this open study. Radiation was delivered with telecobalt machines using standard daily radiation dose of 150-200cGy in 30-35 fractions over a period of 6 weeks. Two lateral parallel opposing fields were used with the portal area generally being 4x6 inches. Patients were randomly allocated to two groups: Patients in the test group were given OE orally three times daily starting 3 days prior to radiotherapy and continuing up to 5 days after completing radiotherapy. Patients in the control arm were not given any drug. The control group and the test group were comparable with respect to presenting features. In the test group the maximum severity and duration of mucositis, skin reaction, and dysphagia were significantly less as compared to the control group. The duration of these side effects as well as the sum scores of toxicity was also significantly less in the OE group. In summary the use of OE with conventional fractionated radiotherapy was feasible without significant safety problems. There was a clinically relevant protection against acute side effects of radiotherapy in the OE group. Not only was the severity of acute side effects less, but the duration was shorter and the time to onset was also delayed.