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)
Authors: Jimenez-Garcia Celia , Perula-de Torres Luis Angel , Villegas-Becerril Enrique , Muñoz-Gavilan Juan Jose , Espinosa-Calvo Maria , Montes-Redondo Gertrudis , Romero-Rodriguez Esperanza ,   Alantel Trial Collaborative Group, Manzanaro Maria Carmen Moreno , Santiago Fatima Ginés , Serrano Carmen Bueno , Ruperto Fabiola Romero , Ramirez Maria Cruz Linares , Román Maria Angeles Quesada , Alcaraz Nieves Muñoz , Rejano Juan Manuel Parras , Estepa Maria Isabel Lopez , Maestre-Serrano Maria Dolores , Villatoro Jaime Monserrat 
Published: January 2024

Abstract
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.