Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
»
2020
INTERVENTION: Laser Therapy Low‐Level Light Therapy Other The 90 patients included in this research will be clinically evaluated for the diagnosis of oral mucositis (Pinheiro et al., 2019) and, during the clinical examination, the medical history will be recorded. Patients will receive oral hygiene instructions and will be divided evenly randomized (www.random.org.br) in 3 groups and 2 subgroups: Subgroup Without ILIB (control): In this treatment group, patients will be evaluated initially according to the degree of mucositis present in the oral cavity, so that, later, treatment can be started. As for the therapy protocols, in the prevention and treatment groups, photodynamic therapy (PDT) using the photosensitizer curcumin (1.5 g / L concentration) will be used diluted in 980 mL of distilled water (adapted from Leite et al., 2014; Andrade et al., 2013) (Formula & Action, São Paulo, SP, Brazil). The patient will be instructed to rinse 20 mL of the solution for 5 min, discarding the contents soon after. Then, the oral cavity will be irradiated with blue LED (UltraLumen SL, Sander do Brasil Ltda., Minas Gerais, MG, Brazil) with 1200 mW of power and a wavelength of 468 nm, for 5 min (Pinheiro et al., 2019). After PDT, photobiomodulation therapy (PBM‐T) will be performed, using the low intensity laser (DMC, São Carlos, São Paulo, Brazil) with 100 mW of power, 660 nm of wavelength, in continuous mode, spot of 0.028 cm², 1 J of energy and flow of 35.7 J / cm². The energy used of 1 J was based on the study of Antunes et al. (2017) and Guedes et al. (2018), in addition to the information contained in the studies by Fekrazad and Chiniforush (2014) and Zecha et al. (2016a). It will be irradiated 26 points for 10 s at each point: one point on each lip commissure (2 points), three points on the mucosa of upper lip, three points on the mu CONDITION: C00‐D48 Other diseases of lip and oral mucosa Stomatitis Stomatitis; other diseases of lip and oral mucosa ; Stomatitis ; Other diseases of lip and oral mucosa PRIMARY OUTCOME: It is expected that ILIB associated or not with photobiomodulation therapy and photodynamic therapy will be an alternative in the prevention and treatment of oral mucositis in cancer patients.; ; In prevention, the percentage and time of onset of oral mucositis lesions after therapies (weekly for 5 weeks) will be measured. In the treatment, before and after its performance, the degree of oral mucositis of the patients will be evaluated according to the WHO. SECONDARY OUTCOME: It is expected to reduce the pro‐inflammatory cytokine IL‐6 and the count of viable bacteria present in saliva of the patients included in the research. ; ; In the first and last session of therapies, the measurement of the pro‐inflammatory cytokine IL‐6 will be performed using the quantitative immunoenzymatic assay kit (ELISA) and the bacterial count, in turn, will be subjected to microbiological evaluation. ; ; The follow‐up of patients will be carried out for a period of six months, during which they will be submitted to clinical reevaluation to verify the appearance / reappearance of oral mucositis and / or any adverse effects of the therapies applied in this study. During the follow‐up period, information about the patients survival and loss of patients or loss of continuity will also be noted (PINHEIRO et al., 2019). If the lesion appears / reappears, the therapy protocols will be applied again and, therefore, patients will receive additional sessions (MARTINS et al., 2019). INCLUSION CRITERIA: Group without oral mucositis the protocol for the prevention of oral mucositis will be used: patients who do not have lesions of oral mucositis; patients diagnosed with head and/or neck cancer who are going to start chemotherapy and/or radiation therapy in the oncology at the Hospital of the Pontifical Catholic University of Campinas; patients or guardians who agree to participate in the research by signing the Informed Consent Form. Group with oral mucositis, lesions already present and treatments will be carried out: patients who present oral mucositis with scores ranging from 1 to 4 according to the WHO classification (Oton‐Leite et al., 2015; Mobadder et al., 2018); patients diagnosed with head and/or neck cancer undergoing chemotherapy and/or radiation therapy at the Hospital's oncology sector the Pontifical Catholic University of Campinas; patients using other prophylactic measures for mucositis, such as oral glutamine, steroids, immunoglobulins, vitamins and
Epistemonikos ID: 6e281f0ad491946e71e66ec0e99ab295b4f887e3
First added on: Apr 23, 2024