Abstract
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 < 0.05). Multivariate analysis confirmed these findings. Sumac-rose rinsing could also postpone the start of oral pain (hazard ratio [HR] 0.02, CI 95% 0.001–0.32, P = 0.001) and high-grade OM (HR 0.28, P = 0.03) compared with benzydamine.
Conclusions
The sumac-rose group had a lower OM rate and grade and higher QoL than the benzydamine group. In addition, the experimental group developed high-grade OM and oral pain later during the radiotherapy course. Further studies need to be conducted to assess the role of sumac and rose water in reducing grade 3–4 mucositis in patients who undergo chemoradiation for head and neck cancer.
Graphical abstract
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Data availability
The datasets analysed during the current study are available from the corresponding author on reasonable request.
Abbreviations
- Gy:
-
Gray
- HG:
-
High grade
- HNC:
-
Head and neck cancer
- OM:
-
Oral mucositis
- OP:
-
Oral pain
- QoL:
-
Quality of life
- PFD:
-
Per fraction dose
- RIOM:
-
Radiation-induced oral mucositis
- ROS:
-
Reactive oxygen species
- RT:
-
Radiotherapy
- TD:
-
Total dose
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Conceptualization: AA, GhH, Methodology: AA, FTH, Software: SP, FTH, Validation: AA, Formal analysis: SP, FTH, Investigation: SP, FT, PA, Resources: AA, GhH, Data Curation: SP, Writing-original draft: SP, AB, FTH, Writing-review & editing: AA, FTH, Visualization: RC, Supervision: AA, GhH, Project administration: AA, GhC, Funding acquisition: N/A.
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Ameri, A., Heydarirad, G., Choopani, R. et al. Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial. J Cancer Res Clin Oncol 149, 7427–7439 (2023). https://doi.org/10.1007/s00432-023-04687-1
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DOI: https://doi.org/10.1007/s00432-023-04687-1