Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials).

BACKGROUND: Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side effects. The latest recommendations of the American Academy of Dermatology establish the use of natural, nourishing, and moisturizing cosmetic products as prevention and the first therapeutic step for dermatitis. Alantel® is a cream developed to reduce redness and irritation, promote the local immune system, combat immunosenescence, and promote the healing of epidermal lesions. The objective was to evaluate the effect of a cream (Alantel) based on natural products at high concentrations for the preventive and curative treatment (at early stages) of radiation-induced dermatitis in patients with breast cancer. METHODS: Our protocol is an experimental, prospective, triple-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel, while the control group will receive another moisturizing cream. Radiotherapy oncology professionals will recruit a total of 88 patients (44 per comparison group) with breast cancer who will receive radiotherapy oncology treatment for 15 days, and they will be randomly allocated to the experimental or control group. Selected patients will be followed up for four visits by primary care physicians for up to 1 week after completion of radiotherapy. The main study variable will be the incidence rate of mild post-radiation dermatitis. An intention-to-treat analysis will be performed, applying a comparison test for independent means and proportions. A bivariate and multivariate analysis will also be developed to check the treatment effect, adjusting for predictive sociodemographic and clinical variables. DISCUSSION: By carrying out this clinical trial, it is expected to verify that Alantel cream, based on natural products at high concentrations, has advantages over a moisturizing cream for the preventive and curative treatment of RD in patients with breast cancer. The COVID-19 pandemic has been influenced by delaying the start of the study. One of the main limitations of this study will be the time required to recruit the patients from the planned sample, given that the selection criteria are restrictive and, although the study is multicenter, recruitment will be coordinated through a single service on radiotherapy oncology. TRIAL REGISTRATION: ClinicalTrials.gov NCT04116151 . Registered on 4 October 2019.

Early nutrition support therapy in patients with head-neck cancer.

BACKGROUND: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. OBJECTIVE: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT). PATIENTS AND METHODS: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. RESULTS: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05). CONCLUSIONS: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients.

Early nutrition support therapy in patients with head-neck cancer / Soporte nutricional precoz en pacientes con cáncer de cabeza y cuello

Background: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. Objective: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT).Patients and methods: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. Results: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05).Conclusions: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients

Antecedentes: la pérdida de peso es un síntoma frecuente en el cáncer de cabeza y cuello (CCC), afecta a un 75-80% de los pacientes y es severa en un 30-50% de los casos. Según las publicaciones de la ESPEN, la valoración nutricional puede realizarse periódicamente y se debe comenzar el soporte nutricional cuando se observe algún déficit nutricional. Objetivo: evaluar el efecto del soporte nutricional precoz (SNP) en marcadores nutricionales y la respuesta terapéutica en pacientes con CCC que reciben radioterapia (RT). Pacientes y métodos: se incluyeron 102 pacientes con CCC que tuviesen al menos dos puntos en la escala de screening nutricional (MUST) antes de recibir RT. Todos los pacientes recibieron SNP, que consistió en asesoramiento nutricional y suplementos orales o nutrición enteral. Resultados: se incluyeron 102 pacientes, el 76% de ellos en estadio IV de la enfermedad. Al final de la RT, después de recibir SNP, se observó una disminución discreta en el índice de masa corporal (IMC) acompañada de aumento de la masa libre de grasa (p < 0,001); los parámetros bioquímicos nutricionales permanecieron estables a pesar de la disminución en la ingesta. La incidencia de mucositis o epitelitis severa fue menor al 40%; el 92% de los pacientes recibieron la totalidad de las sesiones de RT planeadas, mientras que solo el 22,8% interrumpió parcial o totalmente la RT. Aquellos pacientes con desnutrición calórica previa tuvieron un menor cumplimiento terapéutico (p < 0,001). La mortalidad se relacionó con el índice de Karnosfsky, con una mayor pérdida de peso previa a la RT y mayor grado de mucositis o epitelitis (p < 0,05). Conclusiones: aquellos pacientes que reciben SNP mantienen su estado nutricional a pesar de los efectos asociados con RT. El SNP representa una estrategia terapéutica eficiente para prevenir complicaciones relacionadas con la nutrición en pacientes oncológicos

Radiation oncology: future needs and equipment. Current situation in Spain.

Spain's radiation oncology infrastructure has evolved in terms of both quantity and structure since the last analysis was carried out in 1999. The purpose of this paper is to describe the current facilities, basically consisting of external radiotherapeutic units, and to present a calculation model for estimating the number of irradiation units required to guarantee equitable cover for radiotherapeutic treatment. An electronic questionnaire was designed to be accessed via a link on the Spanish Association of Radiotherapy and Oncology Web page. The questionnaire provides details of the current state of Spain's radiotherapeutic facilities, and a descriptive study has been performed with analytical data. The scope of the study included all the centres providing oncology-radiotherapy in Spain. The units analysed encompassed the centres and irradiation units actively providing care in 2004. Ninety-seven centres were detected, in which 177 external radiotherapy units were registered. Forty-five of these were cobalt units and 132 were accelerators. The rate of radiotherapy use in Spain based on the best scientific evidence available and on its rate of use with cancer has been estimated at 61%. The number of external irradiation units available in 2004 (177) is clearly lower than the number desirable (266-316).