Topical application of a cream containing nanoparticles with vitamin E for radiodermatitis prevention in women with breast cancer: A randomized, triple-blind, controlled pilot trial.

Autor: Queiroz Schmidt FM; Federal Institute for Education, Science, and Technology of the South of Minas Gerais, (Instituto Federal de Educação, Ciência e Tecnologia do Sul de Minas Gerais- IFSULDEMINAS), 394, Penha Street, Penha II, 37903-358, Passos, Minas Gerais, Brazil. Electronic address: fernanda.schmidt@ifsuldeminas.edu.br., Serna González CV; Graduate Program in Adult Health Nursing at the School of Nursing of the University of Sao Paulo, (Universidade de Sao Paulo, Escola de Enfermagem-EEUSP), 419, Doctor Enéas de Carvalho Aguiar Avenue, Cerqueira César, 05403-000, Sao Paulo, Sao Paulo, Brazil. Electronic address: carolvsgonzalez@gmail.com., Mattar RC; Cancer Regional Hospital, Holy Mercy Hospital of Passos, (Hospital Regional de Câncer, Santa Casa de Misericórdia de Passos), José Merchioratto Street, Santa Casa, 37904-022, Passos, Minas Gerais, Brazil. Electronic address: rodmattar@hotmail.com., Lopes LB; Pharmacology Department, Biomedical Sciences Institute, University of São Paulo, Brazil (Universidade de São Paulo, Instituto de Ciências Biomédicas), 1524, Professor Lineu Prestes Avenue, Butantã, 05508-000, Sao Paulo, Sao Paulo, Brazil. Electronic address: lublopes@usp.br., Santos MF; Cell and Developmental Biology Department, Institute of Biomedical Sciences, University of São Paulo, (Universidade de São Paulo, Instituto de Ciências Biomédicas), 1524, Professor Lineu Prestes Avenue, Butantã, 05508-000, Sao Paulo, Sao Paulo, Brazil. Electronic address: mfsantos@usp.br., Santos VLCG; Department of Medical-Surgical Nursing at the School of Nursing of the University of Sao Paulo, Brazil (Universidade de Sao Paulo, Escola de Enfermagem-EEUSP), 419, Doctor Enéas de Carvalho Aguiar Avenue, Cerqueira César, 05403-000, Sao Paulo, Sao Paulo, Brazil. Electronic address: veras@usp.br.
Jazyk: angličtina
Zdroj: European journal of oncology nursing : the official journal of European Oncology Nursing Society [Eur J Oncol Nurs] 2022 Dec; Vol. 61, pp. 102230. Date of Electronic Publication: 2022 Oct 29.
DOI: 10.1016/j.ejon.2022.102230
Abstrakt: Purpose: Most topical agents for radiodermatitis prevention are not based on its pathophysiology, mainly caused by the indirect effects of radiation from reactive oxygen species release. Therefore, this study aimed to evaluate the effect of vitamin E-containing nanoparticle cream as an antioxidant for radiodermatitis prevention.
Method: A randomized, triple-blind, parallel pilot study conducted in an Oncology Hospital including 40 adult women with breast cancer, and healthy skin, submitted to radiotherapy, divided into three groups: Intervention (12; 30%) receiving cream with nanoparticles containing vitamin E; Control 1 (14; 35%) cream without nanoparticles or vitamin E; Control 2 (14; 35%) cream with nanoparticles without vitamin E. Incidence, grade and time to onset of radiodermatitis were primary outcomes; health-related quality of life, reported symptoms, and breast temperature were secondary outcomes.
Results: All patients were followed until the end of the study. All had radiodermatitis. There were no significant differences between the study groups regarding radiodermatitis grade, health-related quality of life, and breast temperatures. A protective effect of vitamin E-containing nanoparticle cream was identified regarding the onset time of radiodermatitis in patients who did not receive a boosted radiation dose (p = .03) and the occurrence of mild inframammary erythema (p = .04). Itching was reported by 90% of the women. The definitive calculated sample is 108 volunteers. There were no identified side effects.
Conclusions: A potential protective effect of a cream containing vitamin E nanoparticles was observed. This pilot study presents initial evidence about the role of a nanoencapsulated antioxidant in preventing radiodermatitis.
Trial Registration: No. RBR-784F3Y; UTN-U1111-1201-5923.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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