Benzydamine HCl for prophylaxis of radiation-induced oral mucositis : Results from a multicenter, randomized, double-blind, placebo-controlled clinical trial
✍ Scribed by Joel B. Epstein; Sol Silverman Jr.; Dario A. Paggiarino; Steve Crockett; Mark M. Schubert; Neil N. Senzer; Peter B. Lockhart; Michael J. Gallagher; Douglas E. Peterson; Francis G. Leveque
- Publisher
- John Wiley and Sons
- Year
- 2001
- Tongue
- English
- Weight
- 132 KB
- Volume
- 92
- Category
- Article
- ISSN
- 0008-543X
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✦ Synopsis
BACKGROUND.
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.
METHODS.
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.
RESULTS.
During conventional RT, regimens up to cumulative doses of 5000 centigrays (cGy) benzydamine (n ϭ 69) significantly (P ϭ 0.006) reduced erythema and ulceration by approximately 30% compared with the placebo (n ϭ 76); greater than 33% of benzydamine subjects remained ulcer free compared with 18% of placebo subjects (P ϭ 0.037), and benzydamine significantly delayed the use of systemic analgesics compared with placebo (P Ͻ 0.05). Benzydamine was not effective in subjects (n ϭ 20) receiving accelerated RT doses (Ն 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.
CONCLUSIONS.
Benzydamine oral rinse was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis.