Zhengyuan capsule(正元胶囊)for the treatment of cancer-related fatigue in lung cancer patients undergoing operation:a study proto-col for a randomized controlled trial

• 作者: ZHANG Zhouji ZHANG Ming WU Xiaoting CUI Qing GUO Yijun
• 来源期刊: 中医杂志（英文版）
• 年，卷（期）: 2021,（3）
• 所属期刊栏目: Research Articles
• 页码范围: 485-490
• 页数: 6页
• 语种: 英文
• DOI: 10.19852/j.cnki.jtcm.20210324.001

摘要

OBJECTIVE:To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊)when treating Can-cer-related fatigue(CRF)in lung cancer patients un-dergoing surgical operation.METHODS/DESIGN:This is a single-center,dou-ble-blinded,prospective,and randomized con-trolled trial in the Department of Integrated Chi-nese and Western Medicine,Shanghai Chest Hospi-tal Shanghai JiaoTong University,Shanghai.Eligible participants will be randomly allocated into two groups:a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regi-men therapy.Evaluation will be carried out at four timelines:the participants'screening period,base-line period,the middle of the intervention period,and the end of the intervention period.The prima-ry outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS)measurement system.Secondary measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF)measure-ment system,Traditional Chinese Medicine syn-drome pattern differentiation,levels of immunolog-ic indicators(TNF-α,IL-6,IL-1,T lymphocytes sub-sets and B lymphocyte subsets),patient's pulmo-nary function,performance status scale(PS),self-rating scale of sleep(SRSS),and adverse events(AEs).DISCUSSION:The trial results can provide efficacy and safety data of Zhengyuan capsule when treat-ing CRF in clinic.The data can also be imported in-to the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.