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- Title
Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial.
- Authors
Epstein, Joel B.; Silverman, Sol; Paggiarino, Dario A.; Crockett, Steve; Schubert, Mark M.; Senzer, Neil N.; Lockhart, Peter B.; Gallagher, Michael J.; Peterson, Douglas E.; Leveque, Francis G.; Epstein, J B; Silverman, S Jr; Paggiarino, D A; Crockett, S; Schubert, M M; Senzer, N N; Lockhart, P B; Gallagher, M J; Peterson, D E; Leveque, F G
- Abstract
<bold>Background: </bold>Benzydamine was evaluated in patients with head and neck carcinoma for treatment of radiation-induced oral mucositis, a frequent complication of radiation therapy (RT) for which there is no predictable therapy or preventive treatment currently available.<bold>Methods: </bold>The safety and efficacy of 0.15% benzydamine oral rinse in preventing or decreasing erythema, ulceration, and pain associated with oral mucositis during RT were evaluated in a randomized, placebo-controlled trial conducted in patients with head and neck carcinoma. Subjects were to rinse with 15 mL for 2 minutes, 4-8 times daily before and during RT, and for 2 weeks after completion of RT; study evaluations were conducted before RT and routinely thereafter up to 3 weeks after RT.<bold>Results: </bold>During conventional RT, regimens up to cumulative doses of 5000 centigrays (cGy) benzydamine (n = 69) significantly (P = 0.006) reduced erythema and ulceration by approximately 30% compared with the placebo (n = 76); greater than 33% of benzydamine subjects remained ulcer free compared with 18% of placebo subjects (P = 0.037), and benzydamine significantly delayed the use of systemic analgesics compared with placebo (P < 0.05). Benzydamine was not effective in subjects (n = 20) receiving accelerated RT doses (> or = 220 cGy/day). The incidence of adverse events between treatment groups was comparable without significant differences. Early discontinuation because of adverse events occurred in 6% of benzydamine subjects and 5% of placebo subjects, and there was 1 death (related to the primary diagnosis) in a placebo subject.<bold>Conclusions: </bold>Benzydamine oral rinse was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis.
- Publication
Cancer (0008543X), 2001, Vol 92, Issue 4, p875
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(20010815)92:4<875::AID-CNCR1396>3.0.CO;2-1