Terapia tópica para el tratamiento del dolor en heridas neoplásicas malignas: protocolo de revisión de alcance.

BACKGROUND: A total of 14.5% of cancer patients develop malignant neoplastic wounds (MNW), characterised as friable, exudative, fetid, bleeding, and painful. Some studies report that all patients with MNW experience pain, but there is lack of scientific evidence to support their treatment. OBJECTIVE: To map and examine the existing evidence on topical therapies to manage pain in adult patients with MNW. METHOD: A scoping review protocol was designed, according to the Joanna Briggs Institute (JBI) methodology. The databases CINAHL, LILACS, Embase, Scopus, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR and the grey literature, for searching published and unpublished studies in English, Portuguese and Spanish. The selection will be made by at least two reviewers. The summary of the results will be narrative, with graphs and tables. Qualitative and quantitative studies and reviews will be included, describing the use of topical pain therapies in patients with MNW. CONCLUSION: This study will allow to classify and discuss the available topical therapies, and to recommend future primary studies.

INTRODUCCIÓN: El 14,5% de los pacientes con cáncer desarrolla heridas neoplásicas malignas (HNM), caracterizadas como friables, exudativas, fétidas, sangrantes y dolorosas. Algunos estudios reportan que todos los pacientes con HNM experimentan dolor, pero hay escasez de evidencia científica para fundamentar su tratamiento. OBJETIVO: Mapear y examinar la evidencia existente sobre terapias tópicas para manejar el dolor en pacientes adultos con HNM. MÉTODO: Se diseñó un protocolo de revisión de alcance, de acuerdo con la metodología del Joanna Briggs Institute (JBI). Serán consultadas las bases de datos CINAHL, LILACS, Embase, Scopus, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR y la literatura gris, para la búsqueda de estudios publicados y no publicados en inglés, portugués y español. La selección estará a cargo de, al menos, dos revisores. La síntesis de los resultados será narrativa, con gráficos y tablas. Se incluirán estudios cualitativos, cuantitativos y revisiones, que describan el uso de terapias tópicas para el dolor en pacientes con HNM. CONCLUSIÓN: Este estudio permitirá clasificar y discutir las terapias tópicas disponibles, y recomendar futuros estudios primarios.

Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol.

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

Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol.

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

Clinical protocol for the topical use of a cream with nanoparticles and vitamin E to prevent radiodermatitis in patients with breast cancer]. / Aplicación tópica de crema con nanopartículas con vitamina E para prevenir radiodermatitis en cáncer de mama: protocolo de ensayo clínico.

Objetivo: Poco se conoce sobre la eficacia de productos para la prevención de radiodermatitis, que afecta al 90­95% de las mujeres con cáncer de mama. El uso de antioxidantes es promisorio, sin embargo, poco estudiado. Los autores desarrollaron un protocolo de ensayo clínico para evaluar el efecto potencial de la aplicación de crema con nanopartículas con vitamina E para prevenir radiodermatitis aguda en mujeres con cáncer de mama. Método: El protocolo sugiere que 108 mujeres adultas con cáncer de mama, que estén recibiendo radioterapia, sean incluidas en este ensayo clínico, controlado, aleatorizado y triple ciego, en un hospital oncológico. Se prevé la distribución de pacientes en tres grupos de 36 personas: el grupo A recibirá una crema con nanopartículas lipídicas con vitamina E, el grupo B obtendrá una crema sin nanopartículas ni vitamina E, y el grupo C usará una crema con nanopartículas sin vitamina E. Los resultados primarios evaluarán la incidencia, el grado y el tiempo de surgimiento de la radiodermatitis. Los resultados secundarios se centrarán en la calidad de vida, los síntomas y la temperatura local. Las pacientes serán evaluadas tres veces por semana, desde el inicio de la radioterapia hasta dos semanas después de la última sesión. El presente proyecto fue aprobado por el comité de ética en investigación de las instituciones involucradas.Objective: Little is known about the efficacy of products that aim to prevent radiodermatitis, which affects between 90­95% 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 potential effects of applying a nanoparticle cream with vitamin E to prevent radiodermatitis in patients with breast cancer. Method: The protocol recommends that 108 women with breast cancer, who are receiving radiotherapy, be included in a triple-blinded, randomised, controlled study in an oncology hospital. Patients will be divided in three groups of 36 people each: group A will receive a cream with lipid nanoparticles and vitamin E, group B will obtain a cream without nanoparticles or vitamin E, and group C will receive a cream with nanoparticles without vitamin E. The primary endpoints will evaluate the incidence, degree and time of onset of radiodermatitis. The secondary endpoints will focus on 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. This protocol was approved by the research ethics committee of the institutions involved.