外用中药LC09治疗抗肿瘤靶向药物相关手足皮肤反应的临床研究：一项前瞻性、随机、对照、双盲、单中心临床试验方案
Clinical study for external Chinese herbal medicine LC09 treating hand-foot skin reaction associated with the antitumor targeted drugs: Protocol for a prospective, randomized, controlled, double-blind, and monocentric clinical trial.
作者信息
Wang Gui, Jia Liqun, Pei Yuying, Yu Ran, Gao Yu, Deng Chao, Lou Yanni
机构信息
Department of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Beijing University of Chinese Medicine, Beijing, China.
出版信息
Medicine (Baltimore). 2020 Jan;99(4):e18849. doi: 10.1097/MD.0000000000018849.
BACKGROUND
Molecular targeted anticancer drugs such as multikinase inhibitors have shown obvious therapeutic advantages in a variety of tumors. The occurrence of hand-foot skin reaction (HFSR) is positively correlated with therapeutic effect, but it is also the most common cause of dose limiting toxicity for this treatment. This can lead to interruption or decrement of the treatment, a reduction in quality of life for patients, as well as potentially leading to secondary infections. As a result, the curative effect of targeted anticancer drugs will be negatively impacted. Currently, there is no certain and effective therapy. External use of Chinese herb medicine LC09 in the early treatment of HFSR has shown positive outcomes, but it is necessary to carry out further clinical research to confirm.
OBJECTIVES
The purpose of this study was to investigate the efficacy and safety of topical soaks of Chinese herbal medicine LC09 for HFSR induced by molecular targeted anticancer drugs.
METHODS
The trial is a prospective, randomized, controlled, double-blind, monocentric, and interventional study. A total of 66 patients with HFSR will be recruited and randomly assigned to receive either LC09 Granules or placebo. The primary outcomes are the assessment of HFSR grade and pain score. The secondary outcomes are the evaluation of the quality of life, incidence of targeted drug dosage reduction, and incidence of targeted drug withdrawal.
DISCUSSION
This prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of topical soak treatments with LC09 granules for HFSR. Positive results would provide evidence-based complementary therapeutic approach future treatments of HFSR.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, http://www.chictr.org.cn, ChiCTR1900023679. Registered on 7 June 2019.
背景
多激酶抑制剂等分子靶向抗癌药物在多种肿瘤中显示出明显的治疗优势。手足皮肤反应（HFSR）的发生与治疗效果呈正相关，但它也是这种治疗中剂量限制性毒性的最常见原因。这可能导致治疗中断或减量，降低患者生活质量，并可能导致继发感染。因此，靶向抗癌药物的疗效会受到负面影响。目前，尚无确切有效的治疗方法。中药LC09外用治疗HFSR早期已显示出积极效果，但有必要开展进一步临床研究予以证实。
目的
本研究旨在探讨中药LC09局部浸泡治疗分子靶向抗癌药物所致HFSR的疗效和安全性。
方法
本试验为前瞻性、随机、对照、双盲、单中心干预性研究。共招募66例HFSR患者，随机分为LC09颗粒剂组或安慰剂组。主要观察指标为HFSR分级和疼痛评分评估。次要观察指标为生活质量评估、靶向药物减量发生率和靶向药物停药发生率。
讨论
这项前瞻性随机临床试验将提供关于LC09颗粒剂局部浸泡治疗HFSR的疗效和安全性的有价值数据。阳性结果将为HFSR未来治疗提供循证补充治疗方法。
试验注册
中国临床试验注册中心，http://www.chictr.org.cn，ChiCTR1900023679。于2019年6月7日注册。
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