Department of Pharmacy, National University of Singapore, Singapore, Singapore.
Department of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore.
Trials. 2020 Nov 4;21(1):909. doi: 10.1186/s13063-020-04810-4.
Cancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Traditional Chinese medicine (TCM) could be a potential therapeutic option for CRF. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors. This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors.
This is a single centre, randomized, double-blind, placebo-controlled, parallel trial. Eighty cancer survivors will be recruited and randomized to receive the XBYRT or placebo decoction, in a ratio of 1:1. Participants will consume the XBYRT/placebo decoction daily for 8 weeks and undergo assessments at baseline and 4, 8 and 10 weeks after baseline. The participants will be assessed for patient-reported outcomes (PRO), blood biomarkers and adverse events at each time point. The primary outcome is the overall health and QOL status, at 8 weeks follow-up. The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO. The incidence of adverse events and the effects of the XBYRT decoction on blood biomarkers associated with CRF will also be evaluated.
Efficacy and safety outcomes from this trial will provide important clinical data to guide future large-scale randomized controlled trials, and the evaluation of the objective blood biomarkers can help to delineate the biological mechanisms of CRF.
ClinicalTrials.gov NCT04104113 . Registered on 26 September 2019.
癌症相关疲劳（CRF）是一种常见的影响癌症幸存者的衰弱性疾病。由于缺乏有效的药物干预，CRF 的管理仍然是一个挑战。传统中医（TCM）可能是 CRF 的一种潜在治疗选择。改良香贝养荣汤（XBYRT）是一种 TCM 草药方剂，旨在改善癌症幸存者的疲劳症状。本临床试验旨在评估 XBYRT 改善 CRF 和癌症幸存者生活质量（QOL）的疗效和安全性。
这是一项单中心、随机、双盲、安慰剂对照、平行试验。将招募 80 名癌症幸存者，并将其随机分为 XBYRT 或安慰剂组，比例为 1:1。参与者将每天服用 XBYRT/安慰剂汤，持续 8 周，并在基线和基线后 4、8 和 10 周进行评估。在每个时间点，将评估参与者的患者报告结果（PRO）、血液生物标志物和不良事件。主要终点是 8 周随访时的整体健康和 QOL 状况。次要终点是 XBYRT 对疲劳程度、癌症相关认知障碍和 QOL 的影响，通过 PRO 评估。还将评估不良事件的发生率和 XBYRT 汤对与 CRF 相关的血液生物标志物的影响。
该试验的疗效和安全性结果将为指导未来大规模随机对照试验提供重要的临床数据，评估客观血液生物标志物有助于描绘 CRF 的生物学机制。
ClinicalTrials.gov NCT04104113。于 2019 年 9 月 26 日注册。
