Efficacy of synbiotic mouthwash on salivary TLR2 levels and oral mucositis in head and neck cancer patients undergoing radiotherapy: a randomized clinical trial.

PURPOSE: Head and neck squamous cell carcinoma (HNSCC) is a common type of malignancy that is often treated with radiotherapy. This treatment can lead to the development of oral mucositis. This study investigates the effectiveness of a synbiotic mouthwash in reducing the severity of oral mucositis and in modulating salivary toll-like receptor 2 (TLR2) levels in HNSCC patients undergoing radiotherapy.

MATERIALS AND

METHODS

A triple-blind, placebo-controlled randomized clinical trial was conducted on 44 HNSCC patients, randomly assigned to either a synbiotic mouthwash (synbiotic group) or a normal saline mouthwash (placebo group). Salivary TLR2 levels were measured at baseline and after the completion of radiotherapy and oral mucositis treatment using an enzyme-linked immunosorbent assay (ELISA). The severity of oral mucositis was evaluated at each follow-up session using the MASCC/ISOO grading system. Statistical analyses included generalized estimating equations and Kaplan-Meier survival curves.

RESULTS

Compared to the placebo group, the synbiotic group showed a significant delay in the onset of oral mucositis in grades II and III. Patients in the synbiotic group experienced a slower progression to severe mucositis, with a longer duration of grade II mucositis and fewer cases of grade III mucositis. Moreover, the mean salivary level of TLR2 in patients significantly decreased by the end of the study. However, the two groups found no statistically significant difference in salivary TLR2 levels.

CONCLUSIONS

The synbiotic mouthwash significantly reduced the severity of oral mucositis and delayed its progression in HNSCC patients undergoing radiotherapy. TLR2 levels decreased significantly in both groups. IRCT20230624058564N1, registration date: 2023-08-06. https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02591897/full https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230624058564N1 http://en.irct.ir/trial/70874.