PMID- 34114408
OWN - NLM
STAT- MEDLINE
DCOM- 20220202
LR  - 20220202
IS  - 2589-451X (Electronic)
IS  - 0255-2922 (Linking)
VI  - 41
IP  - 3
DP  - 2021 Jun
TI  - Zhengyuan capsule for the treatment of cancer-related fatigue in lung cancer 
      patients undergoing operation: a study protocol for a randomized controlled 
      trial.
PG  - 486-491
LID - 10.19852/j.cnki.jtcm.20210324.001 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule () when 
      treating Cancer-related fatigue (CRF) in lung cancer patients undergoing surgical 
      operation. METHODS/DESIGN: This is a single-center, double-blinded, prospective, 
      and randomized controlled trial in the Department of Integrated Chinese and 
      Western Medicine, Shanghai Chest Hospital 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 regimen therapy. Evaluation will be carried 
      out at four timelines: the participants' screening period, baseline period, the 
      middle of the intervention period, and the end of the intervention period. The 
      primary 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) measurement system, Traditional Chinese Medicine syndrome pattern 
      differentiation, levels of immunologic indicators (TNF-alpha, IL-6, IL-1, T 
      lymphocytes subsets and B lymphocyte subsets), patient's pulmonary 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 treating CRF in clinic. The data can also be imported 
      into the management and treatment guidelines for CRF in lung cancer patients 
      undergoing operation throughout China.
FAU - Zhang, Zhou-Ji
AU  - Zhang ZJ
AD  - Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital 
      Shanghai JiaoTong University, Shanghai 200030, China.
FAU - Zhang, Ming
AU  - Zhang M
AD  - Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital 
      Shanghai JiaoTong University, Shanghai 200030, China.
FAU - Wu, Xiao-Ting
AU  - Wu XT
AD  - Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital 
      Shanghai JiaoTong University, Shanghai 200030, China.
FAU - Cui, Qing
AU  - Cui Q
AD  - Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital 
      Shanghai JiaoTong University, Shanghai 200030, China.
FAU - Guo, Yi-Jun
AU  - Guo YJ
AD  - Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital 
      Shanghai JiaoTong University, Shanghai 200030, China.
LA  - eng
SI  - ChiCTR/ChiCTR1900022712/ YZJ-HR-ZYJN-02
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - China
TA  - J Tradit Chin Med
JT  - Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan
JID - 8211546
SB  - IM
MH  - China
MH  - Fatigue/drug therapy/etiology
MH  - Humans
MH  - *Lung Neoplasms/complications/drug therapy
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical trial protocol
OT  - Fatigue
OT  - Lung neoplasm
OT  - Postoperative period
OT  - Randomized controlled trial
OT  - Zhengyuan capsule
EDAT- 2021/06/12 06:00
MHDA- 2022/02/03 06:00
CRDT- 2021/06/11 07:16
PHST- 2021/06/11 07:16 [entrez]
PHST- 2021/06/12 06:00 [pubmed]
PHST- 2022/02/03 06:00 [medline]
AID - 3173 [pii]
AID - 10.19852/j.cnki.jtcm.20210324.001 [doi]
PST - ppublish
SO  - J Tradit Chin Med. 2021 Jun;41(3):486-491. doi: 
      10.19852/j.cnki.jtcm.20210324.001.