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.

Allisson Filipe Lopes Martins, Carlos Henrique Pereira, Marília Oliveira Morais, Sebastião Silvério de Sousa-Neto, Marize Campos Valadares, Nilceana Maya Aires Freitas, Cláudio Rodrigues Leles, Elismauro Francisco de Mendonça

Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 2023;31(9):517

PMID: 37566179

Full Text on Springer View on PubMed

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, 7, 14, 21, and 30 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.

Address: Universidade Evangélica de Goiás, Dentistry School, Av. Universitária, s/n-Cidade Universitária, Goiás, Anápolis, CEP 75083-515, Brazil.; Araujo Jorge Cancer Hospital, R. 239, 206-Setor Universitário, Goiás, Goiânia, CEP 74175-120, Brazil.; Laboratory of Oral Pathology, School of Dentistry, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiás, Goiânia, CEP 74605-220, Brazil.; Laboratory of Pharmacology and Cellular Toxicology, Pharmacy Faculty, Universidade Federal de Goiás 5ª Avenida Esquina com Rua 240, s/n-Setor Universitário, Goiás, Goiânia, CEP 74605-170, Brazil.; Department of Radiotherapy, Araujo Jorge Cancer Hospital, R. 239, 206-Setor Universitário, Goiás, Goiânia, CEP 74175-120, Brazil.; Department of Prevention and Oral Rehabilitation, School of Dentistry, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n-Setor Universitário, Goiás, Goiânia, CEP 74605-220, Brazil.; Department of Oral Pathology, School of Dentistry, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil. [email protected].

DOI: 10.1007/s00520-023-07971-5

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https://dx.doi.org/10.1007/s00520-023-07971-5

MeSH Terms: Humans, Bidens, Quality of Life, Curcuma, Stomatitis, Head and Neck Neoplasms, Plant Extracts, Low-Level Light Therapy