Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial

Background Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard...

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Bibliographic Details
Published in:Journal of cancer research and clinical oncology 2023-08, Vol.149 (10), p.7427-7439
Main Authors: Ameri, Ahmad, Heydarirad, Ghazaleh, Choopani, Rasoul, Poshtmahi, Sanaz, Ameri, Pooya, Talebi, Fereshteh, Bagheri Pour, Anahid, Taghizadeh-Hesary, Farzad
Format: Article
Language:English
Subjects:
Benzydamine - therapeutic use
Cancer Research
Chemoradiotherapy
Double-Blind Method
Head & neck cancer
Head and Neck Neoplasms - radiotherapy
Hematology
Humans
Internal Medicine
Medicine
Medicine & Public Health
Mouthwashes - therapeutic use
Mucositis
Multivariate analysis
Oncology
Pain
Quality of Life
Radiation
Radiation Injuries
Radiation therapy
Rhus
Stomatitis - etiology
Stomatitis - prevention & control
Water
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Summary:Background Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard) and a new combination (sumac and rose water) in preventing radiation-induced OM. Methods This was a phase II, triple-blind, active-controlled, randomized trial. The primary endpoint was OM, and the secondary endpoints were oral pain and QoL. Besides, the possible variables defining the outcomes were analyzed using the chi-squared test (univariate analysis) and binomial regression model (multivariate analysis). Results Sumac-rose group had fewer high-grade OM (33% vs. 63%, odds ratio [OR] 0.28, 95% confidence interval [CI 95%] 0.08–0.93, P  = 0.03) and better QoL ( P  
ISSN:0171-5216
1432-1335
DOI:10.1007/s00432-023-04687-1