Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial.
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 = 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.


CONCLUSIONS
Benzydamine oral rinse was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis.
Epstein
J B
JB
British Columbia Cancer Agency, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, BC V5Z-4E6, Canada. jepstein@bcccancer.bc.ca
Silverman
S
S
Paggiarino
D A
DA
Crockett
S
S
Schubert
M M
MM
Senzer
N N
NN
Lockhart
P B
PB
Gallagher
M J
MJ
Peterson
D E
DE
Leveque
F G
FG
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001591:Benzydamine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D009067:Mouthwashes; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009067:Mouthwashes; D001591:Benzydamine