Stomatitis
Conditions
Interventions
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 rec
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
Other
E02.594.540
E02.594
Sponsors
Pontifícia Universidade Católica de Campinas
Lucas Augusto da Silva
Sérgio Luiz Pinheiro
Eligibility
Age
20 Years to 80 Years
Inclusion criteria
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 chlorhexidine, among others; patients or guardians who agree to participate in the research by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Exclusion criteria for both groups, without and with oral mucositis: patients or guardians who do not agree to participate in the research; patients who are unable to rinse with the photosensitizer, due to the vomiting reflex or functional limitations caused tumor, and intubated patients; patients with partial or total loss of the maxilla or mandible due to the tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Brazil
Contacts
Public ContactCentro;Lucas Ciências da Vida;Silva
Pontifícia Universidade Católica de Campinas;Lucas Augusto da Silva
Outcome results
None listed