title: Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial.
abstract: 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.
authors.affiliation: British Columbia Cancer Agency, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, BC V5Z-4E6, Canada. jepstein@bcccancer.bc.ca
authors.forename: J B
authors.initials: JB
authors.lastname: Epstein
authors.forename: S
authors.initials: S
authors.lastname: Silverman
authors.forename: D A
authors.initials: DA
authors.lastname: Paggiarino
authors.forename: S
authors.initials: S
authors.lastname: Crockett
authors.forename: M M
authors.initials: MM
authors.lastname: Schubert
authors.forename: N N
authors.initials: NN
authors.lastname: Senzer
authors.forename: P B
authors.initials: PB
authors.lastname: Lockhart
authors.forename: M J
authors.initials: MJ
authors.lastname: Gallagher
authors.forename: D E
authors.initials: DE
authors.lastname: Peterson
authors.forename: F G
authors.initials: FG
authors.lastname: Leveque
mesh_terms: 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*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009067:Mouthwashes; D001591:Benzydamine