Abstract

summary Background & aims: To assess the efficacy on acute grade 3 or 4 oral mucositis of immune modulating formulae during radiochemotherapy in head and neck neoplasms. Methods: Prospective phase II trial. 40 patients without malnutrition were assigned to receive radiotherapy (66 Gy; 6.5 weeks) combined with cisplatin (D 1, 22 and 43). Patients received an oral supplementation (1 l/day, formula enriched with L-arginine, u-3 fatty acids, and ribonucleic acids) for 5 days before each cycle of chemotherapy. Results: Twenty one (52.5%) patients showed at least one NCI grade 3 or 4 toxicity. Only 5 patients (12.5%) had a grade 3 or 4 NCI oral mucositis. The rate of severe mucositis was 6.8% when compliance with the oral dietary regimen was greater than 75% and 27.3% when compliance with the specialised regimen was less than 75% (P ¼ 0.082). Conclusions: Oral supplementation with an immune modulating formula could reduce severe acute oral mucositis.

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