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 Study (Alantel Trials)

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 and promote the local immune system, combat immunosenescence, as well as 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 (early stages) of radiation-induced dermatitis in patients with breast cancer. Methods: Our protocol is a experimental, prospective, double-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel while the control group will receive a placebo. 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 assigned to the experimental or control group. Selected patients will be followed for four visits by Primary Care physicians for up to one 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: The purpose of this clinical trial is to evaluate the effect of a cream already marketed (Alantel) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in patients with breast cancer. The COVID19 pandemic has 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 is carried out through a single service on radiotheraphy oncology. Trial registration: The clinical trial has been registered in Clinicaltrials.gov (ref. NCT04116151). Registered on October 4, 2019. https://clinicaltrials.gov/ct2/show/ NCT04116151