PMID- 36901517
OWN - NLM
STAT- MEDLINE
DCOM- 20230314
LR  - 20230418
IS  - 1660-4601 (Electronic)
IS  - 1661-7827 (Print)
IS  - 1660-4601 (Linking)
VI  - 20
IP  - 5
DP  - 2023 Mar 3
TI  - Safety and Efficacy of Bojungikki-Tang in Advanced NSCLC Patients Receiving 
      Treatment with Immune Checkpoint Inhibitors: Protocol for a Multicenter, 
      Double-Blind, Randomized, Placebo-Controlled Pilot Trial.
LID - 10.3390/ijerph20054507 [doi]
LID - 4507
AB  - Cancer immunotherapy with immune checkpoint inhibitors (ICIs) is a major 
      treatment option for several types of cancer, including non-small cell lung 
      cancer (NSCLC). The proposed study aims to investigate the safety and efficacy of 
      Bojungikki-tang (BJIKT) therapy (an herbal medicine) in patients with advanced 
      NSCLC treated with ICIs. This multicenter, randomized, placebo-controlled pilot 
      study will be performed at three academic hospitals. Thirty patients with 
      advanced NSCLC, undergoing atezolizumab monotherapy as second- and 
      subsequent-line treatment, will be recruited and randomly assigned to either 
      BJIKT treatment (atezolizumab + BJIKT) or placebo (atezolizumab + placebo). The 
      primary and secondary outcomes are the incidence of adverse events (AEs), 
      including immune- related AEs (irAEs) and non-immune-related AEs (non-irAEs); and 
      early termination rate, withdrawal period, symptom improvement of fatigue, and 
      skeletal muscle loss, respectively. The exploratory outcomes are patient 
      objective response rate and immune profile. This is an ongoing trial. Recruitment 
      started on 25 March 2022 and is expected to be completed by 30 June 2023. This 
      study will provide basic evidence for the safety profiles, including irAEs, of 
      herbal medicine in patients with advanced NSCLC treated with ICIs.
FAU - Ko, Mi Mi
AU  - Ko MM
AUID- ORCID: 0000-0002-5758-4655
AD  - KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 
      34054, Republic of Korea.
FAU - Jeong, Mi-Kyung
AU  - Jeong MK
AUID- ORCID: 0000-0002-0239-0159
AD  - KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 
      34054, Republic of Korea.
FAU - Choi, Chang Min
AU  - Choi CM
AUID- ORCID: 0000-0002-2881-4669
AD  - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, College 
      of Medicine, University of Ulsan, Seoul 05505, Republic of Korea.
FAU - Lee, Seung Hyeun
AU  - Lee SH
AUID- ORCID: 0000-0002-7666-313X
AD  - Division of Pulmonary and Critical Care Medicine, Department of Internal 
      Medicine, Kyung Hee University Medical Center, Kyung Hee University College of 
      Medicine, Seoul 02447, Republic of Korea.
FAU - Chun, Jaemoo
AU  - Chun J
AUID- ORCID: 0000-0003-4191-4063
AD  - KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 
      34054, Republic of Korea.
FAU - Yi, Jin-Mu
AU  - Yi JM
AD  - KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 
      34054, Republic of Korea.
FAU - Jang, Ho
AU  - Jang H
AUID- ORCID: 0000-0001-9869-4562
AD  - KM Data Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic 
      of Korea.
FAU - Lee, Sung Yong
AU  - Lee SY
AD  - Division of Pulmonary, Allergy, and Critical Care Medicine, Department of 
      Internal Medicine, Korea University Guro Hospital, Korea University College of 
      Medicine, Seoul 08308, Republic of Korea.
LA  - eng
GR  - KSN2022240/Korea Institute of Oriental Medicine/
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230303
PL  - Switzerland
TA  - Int J Environ Res Public Health
JT  - International journal of environmental research and public health
JID - 101238455
RN  - 0 (Immune Checkpoint Inhibitors)
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Immune Checkpoint Inhibitors/therapeutic use
MH  - *Lung Neoplasms/drug therapy
MH  - Pilot Projects
MH  - Plant Extracts/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC10002386
OTO - NOTNLM
OT  - Bojungikki-tang
OT  - immune checkpoint inhibitors
OT  - non-small cell lung cancer
COIS- The authors declare no conflict of interest.
EDAT- 2023/03/12 06:00
MHDA- 2023/03/15 06:00
PMCR- 2023/03/03
CRDT- 2023/03/11 01:13
PHST- 2023/01/09 00:00 [received]
PHST- 2023/02/20 00:00 [revised]
PHST- 2023/02/27 00:00 [accepted]
PHST- 2023/03/11 01:13 [entrez]
PHST- 2023/03/12 06:00 [pubmed]
PHST- 2023/03/15 06:00 [medline]
PHST- 2023/03/03 00:00 [pmc-release]
AID - ijerph20054507 [pii]
AID - ijerph-20-04507 [pii]
AID - 10.3390/ijerph20054507 [doi]
PST - epublish
SO  - Int J Environ Res Public Health. 2023 Mar 3;20(5):4507. doi: 
      10.3390/ijerph20054507.