AI Article Synopsis
- - The study investigated the effectiveness of a mucoadhesive formula (FITOPROT) combined with photobiomodulation (PBM) in reducing oral mucositis (OM) in head and neck cancer patients undergoing radiotherapy.
- - Two groups were formed, one receiving FITOPROT and PBM, and the other only PBM, with assessments made over the course of treatment for OM severity and inflammatory cytokine levels.
- - Results showed no significant difference in OM severity between the two groups, but FITOPROT combined with PBM may help maintain a balance of salivary nitrite and cytokines, potentially lowering severe OM cases.
Article Abstract
Purpose: This randomized clinical trial aimed to compare the effects of a mucoadhesive formula, containing curcuminoids from Curcuma longa L. and glycerinated extract of Bidens pilosa L. (FITOPROT), associated with photobiomodulation (PBM), and of PBM exclusively, on the incidence of oral mucositis (OM)-induced by radiotherapy (RT) in the head and neck region, and the salivary expression of inflammatory cytokines, in patients with head neck cancer.
Methods: Patients were randomly assigned into two intervention groups-FITOPROT + PBM (n = 25) or PBM (n = 27). PBM protocol comprised a wavelength of 660 nm, 25 mW, 0.25 J/point, and daily irradiation from the first until the last day of RT. FITOPROT was gargled twice a day. All patients underwent a preventive oral care program throughout the study. OM degree, salivary concentration of nitrite, and inflammatory (IL-1, TNFα, IL-6, IL-8, and IL-12p70), and anti-inflammatory (IL-10) cytokines were assessed at baseline, and at the 7th, 14th, 21st, and 30th RT sessions.
Results: There were no differences in the OM degree between groups, but the RT dose significantly affected the OM. The RT significantly affected the salivary nitrite, TNFα, IL-1β, and IL-10 concentrations.
Conclusion: FITOPROT associated with PBM showed limited effects on preventing the incidence of severe OM compared to PBM alone. However, FITOPROT + PBM may be associated with nitrite and cytokine balance, which may contribute to the occurrence of fewer cases of severe OM.
Trial Registration: Brazilian Clinical Trials database (ReBEC; RBR-9vddmr), registered UTN code: U1111-1193-2066, registered in August 8th, 2017.
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| http://dx.doi.org/10.1007/s00520-024-08842-3 | DOI Listing |
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