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Master's Dissertation
DOI
https://doi.org/10.11606/D.25.2023.tde-17012024-184118
Document
Author
Full name
Vivian Palata Viola
Institute/School/College
Knowledge Area
Date of Defense
Published
Bauru, 2023
Supervisor
Committee
Santos, Paulo Sergio da Silva (President)
Mamani, Mariela Peralta
Medeiros, Frederico Buhatem
Zangrando, Mariana Schutzer Ragghianti
Title in Portuguese
Avaliação do efeito do uso de enxaguante bucal a base de ftalocianina em pacientes submetidos a tratamento oncológico de cabeça e pescoço com mucosite oral
Keywords in Portuguese
Câncer de cabeça e pescoço
Ftalocianina
Mucosite oral
Qualidade de vida
Radioterapia
Abstract in Portuguese
Este estudo clínico prospectivo randomizado triplo cego teve como objetivo verificar a resposta clínica anti-inflamatória da ftalocianina de ferro autoativada como substância ativa de um bochecho adjuvante no tratamento e controle da mucosite oral (MO) em indivíduos em tratamento para câncer de cabeça e pescoço (CCP) com radioterapia (RT) e, secundariamente, foi também realizado a avaliação da qualidade de vida (QV) dos mesmos. Materiais e métodos: Participaram deste estudo 28 indivíduos em tratamento para CCP no Hospital de Câncer de Barretos Hospital de Amor, randomizados em 2 grupos, sendo 21 incluídos, 10 do grupo ftalocianina (GF) e 11 do grupo substância não ativa (GNA). Foram orientados a realizar bochecho de 1 minuto com 5ml da solução oferecida, diariamente, 3 vezes ao dia, da 1ª até sua última sessão de RT e avaliados clinicamente em 3 momentos para graduação de MO a partir da escala de MO da Organização Mundial da Saúde (OMS) e OMS Modificada e em 4 momentos para avaliação da QV a partir dos questionários European Organization for Research and Treatment of Cancer Quality of Life Questionaire Head and Neck (EORTC QLQ H&N43) e Oral Health Impact Profile (OHIP-14). Resultados: Tratando-se de avaliação de MO, nenhum grupo atingiu o score máximo segundo os critérios OMS. Quando avaliados segundo os critérios da escala OMS Modificada, a maioria dos participantes que atingiram o grau máximo da escala faziam parte do grupo GNA, sendo 2 no tempo I, 3 no tempo II e 2 no tempo III. Possivelmente devido ao número de participantes e heterogeneidade da amostra a maioria das análises estatísticas apresentaram valor de p = n.s. durante as avaliações dos graus de MO. Quanto as avaliações da QV, pode-se observar uma variância de impacto leve a moderado em ambos os grupos nos tempos I e II, e nos tempos III e IV foi possível notar crescente aumento nos impactos moderado a grave dentre as dimensões avaliadas. O tempo III de avaliação foi o que apresentou maiores diferenças entre os valores das médias. Avaliando descritivamente os dados obtidos pode-se observar uma relação entre a piora dos índices de MO e também da QV em ambos os grupos. Conclusão: Este pode ser considerado um estudo inicial para o conhecimento geral da atuação da ftalocianina na resposta clínica inflamatória da MO e sua eficácia. Quanto a QV, é notável o impacto do tratamento do CCP nesse aspecto, podendo ser possível visualizar que o período de maior gravidade dos quadros são os momentos finais de tratamento radioterápico.
Title in English
Evaluation of the effect of the use of phthalocyanine-based mouthwash in patients undergoing head and neck cancer treatment with oral mucositis
Keywords in English
Head and neck cancer
Oral mucositis
Phthalocyanine
Quality of life
Radiotherapy
Abstract in English
The aim of this prospective randomized triple-blind clinical study was to verify the clinical antiinflammatory response of self-activated iron phthalocyanine as the active substance of an adjuvant mouthwash in the treatment and control of oral mucositis (OM) in individuals undergoing treatment for head and neck cancer (HNC) with radiotherapy (RT) and, as a second stage, to evaluate their quality of life (QoL). Materials and methods: 28 individuals undergoing treatment for HNC at the Barretos Cancer Hospital - Hospital de Amor were randomized into 2 groups, 21 of which were included, 10 in the phthalocyanine group (GF) and 11 in the non-active substance group (GNA). They received instructions to rinse their mouths for 1 minute with 5ml of the solution offered, 3 times a day, from the 1st to the last RT session and were clinically evaluated at 3 moments to grade OM using the World Health Organization (WHO) and Modified WHO OM scales and at 4 moments to evaluate QoL using the European Organization for Research and Treatment of Cancer Quality of Life Questionaire Head and Neck (EORTC - QLQ H&N43) and Oral Health Impact Profile (OHIP-14) questionnaires. Results: When it came to assessing OM, no group achieved the maximum score according to the WHO criteria. When assessed according to the criteria of the Modified WHO scale, most of the participants who reached the maximum score on the scale were in the GNA group, 2 at time I, 3 at time II and 2 at time III. Results: In relation to OW evaluation, no group reached the maximum score according to the WHO criteria. When evaluated according to the criteria of the Modified WHO scale, most of the participants who reached the maximum score on the scale were part of the GNA group, 2 at time I, 3 at time II and 2 at time III. Possibly due to the number of participants and the heterogeneity of the sample, most of the statistical analyses showed a pvalue = n.s. when evaluating the degrees of OM. With the evaluations of QoL, it was possible to observe a range of mild to moderate impacts in both groups at times I and II, and at times III and IV it was possible to observe a progressive increase in moderate to severe impacts among the dimensions evaluated. Time III showed the biggest differences between the mean values. A descriptive evaluation of the data obtained indicates a relationship between the worsening of OM indices and QoL in both groups. Conclusion: This can be considered an initial study to understand the general role of phthalocyanine in the clinical inflammatory response of OM and its efficacy. As for QoL, the impact of HNC treatment on this aspect is notable, and it can be seen that the period of most severe symptoms are the final moments of radiotherapy treatment.
 
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Publishing Date
2024-02-05
 
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