Effects of a mucoadhesive phytomedicine (Curcuma longa L. and Bidens pilosa L.) on radiotherapy-induced oral mucositis and quality of life of patients undergoing head and neck cancer treatment: randomized clinical trial
Authors:
- Allisson Filipe Lopes MartinsAMAllisson Filipe Lopes Martins
- Carlos Henrique PereiraCPCarlos Henrique Pereira
- Marília Oliveira MoraisMMMarília Oliveira Morais
- Sebastião Silvério de Sousa-NetoSSSebastião Silvério de Sousa-Neto
- Marize Campos ValadaresMVMarize Campos Valadares
- Nilceana Maya Aires FreitasNFNilceana Maya Aires Freitas
- Cláudio Rodrigues LelesCLCláudio Rodrigues Leles
- Elismauro Francisco de MendonçaEMElismauro Francisco de Mendonça
- 11 August 2023
- journal article
- research article
- Published by Springer Nature in Supportive Care in Cancer
- Vol. 31 (9) , 1-14
Abstract
Purpose To assess the effect of a mucoadhesive herbal medicine containing curcuminoids and a glycerinated extract of Bidens pilosa L. (FITOPROT) in association with photobiomodulation (PBM) therapy and a Preventive Oral Care Program (POCP) compared to PBM and POCP in the treatment of radiotherapy (RT)-induced oral mucositis (ROM) and in the quality of life of these patients. Methods A double-blind clinical trial was performed with head and neck cancer patients undergoing RT or chemoradiotherapy. Participants were randomized into two groups: Group 1 (n=27): PBM and POCP; and Group 2 (n=25): PBM, POCP and FITOPROT. The PBM protocol was daily irradiation, 660 nm, 25mW, 0.25 J/point from the first until the last day of RT. The FITOPROT was used as mouthwash twice a day. ROM was evaluated based on the scales of the World Health Organization and National Cancer Institute. The quality of life was evaluated using the University of Washington Questionnaire, OHIP-14 and Patient-Reported Oral Mucositis Symptom Scale. The MMAS-8 questionnaire was used to evaluated the adherence to POCP and FITOPROT. Data were collected at baseline, 7th, 14th, 21st, and 30th RT sessions. Results No statistical differences were found between the groups for the ROM evaluation. Both groups experienced worsening of the quality of life during the RT. No statistically significant differences between groups were observed for any of the instruments evaluated. Conclusion The results suggest that PBM associated with FITOPROT and POCP control the severity of ROM and stabilize the QoL of patients with head and neck cancer. Trial registration Brazilian Registry of Clinical Trials (ReBEC-RBR-9vddmr; UTN code: U1111-1193-2066), registered in August 8th, 2017.Keywords
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