Oral mucositis management with photobiomodulation, Bidens pilosa L. (Asteraceae) and Curcuma longa L. (Zingiberaceae), the FITOPROT herbal medicine, and its influence on inflammatory cytokine levels: a randomized clinical trial

• Published in: Supportive care in cancer 2024-09, Vol.32 (9), p.628, Article 628
• Main Authors: Pereira, Carlos Henrique, Martins, Allisson Filipe Lopes, Morais, Marília Oliveira, de Sousa-Neto, Sebastião Silvério, da Silva, Artur Christian Garcia, Arantes, Diego Antonio Costa, De Oliveira Moreira, Victor Hugo Lopes, Valadares, Marize Campos, Freitas, Nilceana Maya Aires, Leles, Cláudio Rodrigues, Mendonça, Elismauro Francisco
• Format: Article
• Language: English
• Subjects: Adult; Aged; Bidens; Clinical trials; Curcuma; Cytokines; Cytokines - metabolism; Female; Head and Neck Neoplasms - radiotherapy; Humans; Inflammation; Light therapy; Low-Level Light Therapy - methods; Male; Medicine; Medicine & Public Health; Middle Aged; Mucositis; Nursing; Nursing Research; Oncology; Oral diseases; Pain Medicine; Phytotherapy - methods; Plant Extracts - administration & dosage; Plant Extracts - pharmacology; Radiation therapy; Rehabilitation Medicine; Saliva; Side effects; Stomatitis - drug therapy; Stomatitis - etiology; Stomatitis - prevention & control
• ISSN: 0941-4355; 1433-7339; 1433-7339
• DOI: 10.1007/s00520-024-08842-3

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.