Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers
Gujral M.S.1, Patnaik P.M. 2, Kaul R. 1, Parikh H.K. 3, Conradt C. 4, Tamhankar C.P. 5, Daftary G.V. 5
1SGPT Cancer Hospital, M.Y. Hospital Campus, Indore, India
2AH Regional Cancer Centre, Cuttack, India
3Tata Memorial Hospital, Parel, Mumbai, India
4Department of Medical Biometry, University of Heidelberg, Germany
5SIRO Research Foundation, Thane, India
Cancer Chemother Pharmacol 2001, Vol. 47, Suppl: July 2001, S23 - S28
515 KA (2-14-2)-(20-00-2)
Abstract
Purpose: 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.
Methods: Patients with stage T3/T4 head and neck cancer were
eligible. One hundred patients from two centres were entered into the study. 60CoGamma-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.
Results: 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.
Conclusions: 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.
Key words Radiation therapy • Mucositis • Enzyme therapy
• Acute reaction • Side effects • Supportive care