A prospective phase II study evaluating the efficacy of oral immune modulating formulae on acute oral mucositis during radiochemotherapy in head and neck neoplasms
2011
Assenat, E. | Latournerie, M. | Thézenas, S. | Gaillet, S. | Janiszewski, C. | Flori, N. | Dupuy, A.M. | Azria, D. | Crapez, E. | Garrel, R. | Senesse, P.
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, ω-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 = 0.082). CONCLUSIONS: Oral supplementation with an immune modulating formula could reduce severe acute oral mucositis.
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