Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo-controlled, double-blind study.

ABSTRACT

OBJECTIVE: To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation. DESIGN: Prospective, randomized, placebo-controlled, double-blind trial. SETTING: University hospital, Germany. PATIENTS 48 patients who had radiotherapy to the head and neck. MAIN OUTCOME MEASURES: Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score). RESULTS: 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P=0.07). The RTOG score showed significantly fewer acute side-effects of radiation in the experimental arm (P<0.05). CONCLUSION: The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis.