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

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.

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