Investigação da terapia de fotobiomodulação (TF) associada ao fitoprot em relação a TF exclusiva no tratamento da mucosite oral em pacientes com câncer de cabeça e pescoço submetidos a quimiorradioterapia ou radioterapia

Abstract

Oral mucositis (OM) is a serious adverse effect of an inflammatory nature, most frequently resulting from Radiotherapy (RT) with or without Chemotherapy (CT), which can affect the quality of life of patients and result in the interruption of cancer therapy. Photobiomodulation therapy (PT), which uses low-level laser, has been widely investigated and applied for the prevention and control of OM due to its biological effects on analgesia and anti-inflammatory properties. In addition to this, alternative therapies such as the use of curcumin, which is a substance extracted from the plant Curcuma longa (CL), and which has anti-inflammatory properties, have also been used. Bidens pilosa (BP), for example, popularly known as “Picão Preto”, and which also has anti-inflammatory properties, has been investigated. The association of CL curcuminoid extract components (Zingiberacea) and BP glycerin extract (Asteraceae) made it possible to develop a phytotherapic in the form of a mouthwash called FITOPROT, which has been used in clinical research for the control of OM. Objective: To investigate the use of PT and use of FITOPROT combined with the Preventive Oral Care Protocol (POCP) compared to the exclusive use of PT and POCP in the prevention, of OM of patients undergoing RT or QRT in the head and neck region. Material and method: A double-blind clinical trial was carried out with 52 participants with head and neck cancer (HNC) undergoing RT or QRT randomized into two groups: Group 1: PT and POCP (n=27 participants) and Group 2: PT, FITOPROT and POCP (n=25 participants). All participants performed RT five times a week (Monday to Friday) using a low power diode laser (660 nm), 25mW, energy of 0.24 J/point and fluence of 6.2 J/cm². The use of FITOPROT was performed through daily mouthwash twice a day. Clinical evaluation of OM (based on the scales of the World Health Organization-WHO and National Cancer Institute - NCI), saliva analysis (pro and anti-inflammatory cytokines and nitrite), Morisky therapeutic adherence scale (MMAS- 8) and quality of life investigation [OHIP-14 questionnaires, University of Washington (UW-QoL) and Patient-Reported Oral Mucositis Symptom Scale – PROMS]. All data were collected before (baseline-0) and after the beginning of the therapeutic protocol in the 7th, 14th, 21st and 30th RT sessions. Results: In the clinical evaluation of OM, regardless of the severity and type of classification used (WHO and NCI), no statistical differences were found between the groups. A higher incidence of severe OM was observed in the 21st and 30th sessions of RT in group 2, when the groups were compared with each other, with no statistically significant difference. With reference to inflammatory mediators, IL-6 presented similar results between the groups and, interestingly, a trend towards an increase in IL-6 levels was observed in both groups from the 21st session onwards. IL-1β had a lower concentration in the 21st RT session in group 2 when compared to group 1. IL-8 had higher concentrations in both groups, regardless of the number of sessions, with a tendency to increase in group 2 and did not show statistical significance . The TNF-α concentration, despite being low, there was a statistical difference in the 14th and 21st RT sessions in group 1 (p=0.008; p=0.016). Interleukin 12p70 was statistically significant in group 1 at baseline (p=0.003) and 14th RT session (p=0.035), despite the low concentration in both groups. IL-10, on the other hand, showed statistical significance in the 14th session of RT (p=0.013) in group 1 when compared to group 2. Analysis of salivary concentration of nitrite levels indicated lower concentrations in the 14th and 30th session of RT and showed no statistically significant differences. significant when the groups were compared with each other. As for adherence to the PPO, there was a greater adherence of participants in the 21st session in group 2, however, there was no significant difference between the groups. In the results of quality of life, a worsening in quality of life was observed from the 21st session in group 2, and there were no statistical differences between the groups. Pain was reported substantially by group 2. Higher patient-reported OM symptom scores were observed in group 2 from the 21st RT session.