Bochecho com Camomila e Ácido Hialurônico para tratamento de feridas na boca causadas pela Radioterapia

INTERVENTION: This is a two‐arm, double‐blind, randomized controlled clinical trial. A total of 70 people with head and neck cancer undergoing radiotherapy or chemoradiotherapy, who meet the eligibility criteria and agree to participate and sign the Informed Consent Form, will be probabilistically allocated to one or the other intervention group (group A n=35 or group B n=35) using a sequence of numbers generated on the website (www.randomizer.org) by an independent collaborator who will not participate in the study analyses. For each group, letters A and B, corresponding to the groups, will be prepared, placed in opaque envelopes, and numbered in ascending order. The envelope with the corresponding group will only be opened at the first radiotherapy (RT) session. Participants in group A (control) will receive photobiomodulation therapy (PBMT) throughout the treatment period, receiving therapy every day that radiotherapy is performed (5 times a week), and the preventive dental protocol (PDP), which consists of a series of care and guidance on oral adverse events, including prescription of 0.05% sodium fluoride solution (10ml 3 times a day) for dentate participants, elimination of irritation focus, mucosal hydration measures, and supervision and maintenance of oral hygiene. Participants in group B (intervention) will receive photobiomodulation therapy (PBMT) plus the preventive dental protocol (PDP) and a chamomile, hyaluronic acid, and licorice‐based mouthwash (CARE&PROT), which will be administered in a 5ml dose for 30 seconds every day during treatment. Participants will complete three questionnaires: OHIP‐14 (Oral Health Impact Profile‐14), PROMs (Patient‐Reported Outcomes Measures), and MMAS‐8 (Morisky Medication Adherence Scale‐8), to assess quality of life, symptoms of oral CONDITION: E02.594.540 Stomatitis ; Low‐Level Light Therapy PRIMARY OUTCOME: The intervention group is expected to present with less frequent and less severe oral mucositis, which will be assessed through clinical photographs that will be reliable in terms of severity according to the scales of the National Cancer Institute (NCI) and the World Health Organization (WHO) INCLUSION CRITERIA: Participants of both genders; over 18 years of age; with head and neck cancer; who will undergo radiotherapy or chemoradiotherapy with a minimum total dose of 60 Gy and a minimum daily dose of 2 Gy; performance status score between 0 and 2 SECONDARY OUTCOME: Analyze the occurrence of radiotherapy interruptions considering the causes, number of times, and duration of the interruption Assess the perception of oral mucositis symptoms using the PROMs (Patient‐Reported Outcome Measures) questionnaire To assess the impact of therapeutic protocols on quality of life using the OHIP‐14 (Oral ; Health Impact Profile 14) questionnaire To comparatively measure salivary levels of pro‐ and anti‐inflammatory mediators between groups according to the established therapeutic protocol using flow cytometry assay (CBA ‐ cytometric bead array) To describe the sociodemographic and clinical‐pathological profile of the selected participants To investigate adherence to treatment based on the therapeutic protocols established for each group using the MMAS‐8 (Morisky Medication Adherence Scale 8) questionnaire