Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
Western Sydney University, Penrith, NSW, Australia.
Integr Cancer Ther. 2021 Jan-Dec;20:15347354211002919. doi: 10.1177/15347354211002919.
To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial.
METHODS/DESIGN: We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained.
This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS.
ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.
提供关于一种中药（复方阿胶浆，FFEJS）缓解癌症相关乏力（CRF）的益处的更高水平证据，本文描述了一项随机对照试验的方案。
方法/设计：我们在中国针对 3 种癌症设计了一项双盲、安慰剂对照、分层区组随机临床试验，以评估 FFEJS 对 CRF 的疗效。根据随机序列和患者入组的医院，将参与者等分为 FFEJS 组或安慰剂组。每位患者将每天服用 3 次、每次 20ml 的研究用 FFEJS 或安慰剂，共 6 周。随访期为另外的 4 周，以评估安全性。主要结局是用修订版 Piper 疲劳量表中文版（RPFS-CV）评估的疲劳改善程度的差异。次要结局包括疲劳的变化（通过常规血液检查和外周血激素测量）和生活质量（通过埃德蒙顿症状评估量表和癌症治疗功能评估量表测量）。通过肝、肾或心脏损伤来测量患者安全性，并在整个研究过程中监测 FFEJS 促进肿瘤生长和进展的风险。主要通过每获得一个质量调整生命年的增量成本来评估成本效益。
本文通过探讨 FFEJS 治疗晚期癌症患者 CRF 的疗效、安全性和成本效益，描述了一种用于 CRF 的中药复方的研究设计。
ClinicalTrials.gov，NCT04147312。于 2019 年 9 月 1 日注册。
