Estudo piloto de ensaio clínico com creme radioprotetor em pacientes com câncer de mama

• Ano de defesa: 2024
• Autor(a) principal: Cotrim, Renata de Oliveira Alves
• Orientador(a): Gerenutti, Marli
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso embargado
• Idioma: por
• Instituição de defesa: Pontifícia Universidade Católica de São Paulo
• Programa de Pós-Graduação: Programa de Pós-Graduação em Biomateriais e Medicina Regenerativa
• Departamento: Faculdade de Ciências Médicas e da Saúde
• País: Brasil
• Palavras-chave em Português: Neoplasia de mama; Radiodermatite; Protetores contra radiação
• Palavras-chave em Inglês: Breast neoplasms; Radiodermatitis; Radiation-protective agents
• Área do conhecimento CNPq: CNPQ::CIENCIAS DA SAUDE
• Link de acesso: https://repositorio.pucsp.br/jspui/handle/handle/41961

Introduction. Cancer affects a significant proportion of individuals, in 2020 alone, 10 million patients died due to the pathology worldwide. In Brazil, each year, there are 232 thousand deaths and 450 thousand newly diagnosed cases. Breast cancer is the second most common type of cancer among women, and around 2.3 million new cases were estimated for the year 2023 worldwide. Regarding the measures that comprise treatment, in addition to the surgical procedure on the breast, current protocols include radiotherapy as localized therapy. However, problems resulting from damage to the skin caused by radiation, such as acute and chronic radiodermatitis, occasionally end up causing enormous discomfort to patients and, in more extreme cases, treatment is interrupted so that the skin can recover, usually hindering the fight against the tumor. The management of radiodermatitis is a priority in the care of those undergoing treatment since there is no consensus on the prevention and treatment of radiation injuries. A cream to be used in radiotherapy which, as well as moisturizing, protects the skin and only the skin, minimizing the appearance of radiodermatitis, could be considered a breakthrough in this sector. Objective. To prove the effectiveness of the invention called pre-radiotherapy topical radioprotector (RTP) in reducing side effects in breast cancer patients treated with radiotherapy. Methodology. It is a pilot, prospective, open clinical trial in women with breast cancer, with indication of intensity modulated radiotherapy, in total fractions of 40 or 48 Gy, in a linear electron accelerator, at the Radiotherapy Center of the Sorocaba Hospital Complex, SP. Two stages of RPT evaluation were carried out, which was applied minutes before the daily radiotherapy fractions. The study initially consisted of evaluating safety and doseresponse in two groups (n = 5), at concentrations of 1% (A) and 3% (B); and then, the effectiveness of RTP (n = 20) at a concentration of 3% (C) was evaluated, except for those who used the cream at a concentration of 1%. The patients were clinically evaluated every week, during radiotherapy treatment, using a specific questionnaire and a consensus between the CTCAE, RTOG and LENT/SOMA classifications. Results. None of the patients were adverse reaction to the use of the formulation. In the group A, three patients were observed with grade II radiodermatitis and two with grade I. In the group B, four patients had grade I and one grade II radiodermatitis. The RTP was dose dependent. Regarding its effectiveness, in the group C, seventeen patients (85%) developed grade I radiodermatitis, one (5%) grade II radiodermatitis, one (5%) grade III radiodermatitis and one (5%) did not present radiodermatitis. Grade IV and V radiodermatitis were not observed in the study. All patients had a delay in the appearance of erythema during radiotherapy treatment. Conclusion. The RTP suggests radioprotective activity in patients with breast cancer during external beam radiotherapy and this protection is dose dependent. At a final concentration of 3%, RTP was able to delay the appearance of signs and symptoms and minimize chronic radiodermatitis