背景:皮炎是由多种原因引起的皮肤病,包括放射治疗。药物治疗可以变得慢性,并且不能免除副作用。美国皮肤病学会的最新建议建立了使用自然,滋养,和保湿化妆品作为预防和治疗皮炎的第一步。Alantel®是一种为减少发红和刺激而开发的乳霜,促进局部免疫系统,对抗免疫衰老,促进表皮病变的愈合。目的是评估基于高浓度天然产物的乳膏(Alantel)对乳腺癌患者放射性皮炎的预防和治疗(早期)的作用。
方法:我们的方案是实验性的,prospective,三盲,多中心,具有两个平行臂的对照临床试验。实验组将使用Alantel治疗,而对照组将接受另一种保湿霜。放疗肿瘤专业人员将招募88名乳腺癌患者(每个对照组44名),他们将接受放疗肿瘤治疗15天,他们将被随机分配到实验组或对照组。选定的患者将在完成放疗后由初级保健医生随访4次,为期1周。主要研究变量将是轻度放射后皮炎的发生率。将进行意向治疗分析,对独立的均值和比例进行比较测试。还将开发双变量和多变量分析来检查治疗效果,调整预测社会人口统计学和临床变量。
结论:通过进行这项临床试验,预计可以验证Alantel霜,基于高浓度的天然产物,与保湿霜相比,在乳腺癌患者中预防和治疗RD方面具有优势。COVID-19大流行受到了推迟研究开始的影响。这项研究的主要限制之一是从计划样本中招募患者所需的时间,鉴于选择标准是限制性的,尽管这项研究是多中心的,招募将通过一项关于放射治疗肿瘤学的单一服务进行协调。
背景:ClinicalTrials.govNCT04116151。2019年10月4日注册。
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04116151 . Registered on 4 October 2019.