Research: SCHMIDT and COLLEAGUES

Listed in Issue 279

Abstract

SCHMIDT and Colleagues, 1 Instituto Federal de Educação, Ciência e Tecnologia do Sul de Minas Gerais (IFSULDEMINAS), Passos, Minas Gerais, Brazil; 2 Graduate Program in Adult Health Nursing, Universidade de São Paulo, Escola de Enfermagem (EEUSP), Sao Paulo, Brazil; 3 Cancer Regional Hospital, Santa Casa de Misericórdia de Passos, Minas Gerais, Brazil;       4 Pharmacology Department, Universidade de São Paulo, Instituto de Ciências Biomédicas (ICB-USP), Sao Pablo, Brazil; 5 Cell Biology and Development Department, Universidade de São Paulo, Instituto de Ciências Biomédicas (ICB-USP), Sao Pablo, Brazil; 6 Department of Medial-Surgical Nursing, Universidade de São Paulo, Escola de Enfermagem (EEUSP), Sao Paulo, Brazil present a triple-blinded, randomized, controlled study protocol to evaluate the effects of applying a cream containing nanoparticles with vitamin E to prevent radiodermatitis in patients with breast cancer.

Background

Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90-95% of women with breast cancer. The use of antioxidants is promising, however, there is a lack of evidence on their effectiveness. Here, the authors present a clinical trial protocol to evaluate the effects of applying a cream containing nanoparticles with vitamin E to prevent radiodermatitis in patients with breast cancer.

Methodology

The protocol recommends that 108 women with breast cancer, receiving radiotherapy, are included in this triple-blinded, randomized, controlled study at an oncology hospital. Patients will be divided in three groups of 36 individuals each: group A will receive a cream with lipid nanoparticles and vitamin E, group B will receive a cream without nanoparticles nor vitamin E, and group C will receive a cream with nanoparticles without vitamin E.

Results

The primary endpoints will evaluate the incidence, degree, and time of onset of radiodermatitis. The secondary endpoints will focus on the quality of life, symptoms, and local temperature. Patients will be assessed three times a week, from the start of their radiotherapy treatment to two weeks after the last session.

Conclusion

This protocol was approved by the research ethics committee of the institutions involved and registered on an international trials database.

References

Fernanda Mateus Queiróz Schmidt  1 , Carol V Serna González  2 , Rodrigo Calixto Mattar  3 , Luciana Biagini Lopes  4 , Marinilce Fagundes Dos Santos  5 , Vera L C de Gouveia Santos  6. Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol. J Wound Care; 29(LatAm sup 1): 18-26. doi: 10.12968/jowc.2020.29.LatAm_sup_1.18.eng. Jan 1 2020.

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