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Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial.
Cancer 2001; 92(4):875-85C

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+Show Affiliations

British Columbia Cancer Agency, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, BC V5Z-4E6, Canada. jepstein@bcccancer.bc.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11550161

Citation

Epstein, J B., et al. "Benzydamine HCl for Prophylaxis of Radiation-induced Oral Mucositis: Results From a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial." Cancer, vol. 92, no. 4, 2001, pp. 875-85.
Epstein JB, Silverman S, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-85.
Epstein, J. B., Silverman, S., Paggiarino, D. A., Crockett, S., Schubert, M. M., Senzer, N. N., ... Leveque, F. G. (2001). Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer, 92(4), pp. 875-85.
Epstein JB, et al. Benzydamine HCl for Prophylaxis of Radiation-induced Oral Mucositis: Results From a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial. Cancer. 2001 Aug 15;92(4):875-85. PubMed PMID: 11550161.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. AU - Epstein,J B, AU - Silverman,S,Jr AU - Paggiarino,D A, AU - Crockett,S, AU - Schubert,M M, AU - Senzer,N N, AU - Lockhart,P B, AU - Gallagher,M J, AU - Peterson,D E, AU - Leveque,F G, PY - 2001/9/11/pubmed PY - 2001/9/21/medline PY - 2001/9/11/entrez SP - 875 EP - 85 JF - Cancer JO - Cancer VL - 92 IS - 4 N2 - 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/11550161/Benzydamine_HCl_for_prophylaxis_of_radiation_induced_oral_mucositis:_results_from_a_multicenter_randomized_double_blind_placebo_controlled_clinical_trial_ L2 - https://ClinicalTrials.gov/search/term=11550161 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -