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Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients

INTRODUCTION: Neoadjuvant chemotherapy (NAC) plays an important role in downgrading preoperative tumor size, providing information on regimen activity, and increases treatment efficacy in breast cancer patients. An increasing number of patients have sought Traditional Chinese Medicine (TCM) during N...

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Autores principales: Zhang, Xinyue, Hu, Minhao, Li, Siyu, Sha, Shanyan, Mao, Ruoyu, Liu, Yu, Li, Qiong, Lu, Qing, Chen, Weili, Zhang, Ying, Wang, Rong, Xu, Huaijin, Wang, Jieqiong, Qiao, Yu, Chen, Ziyi, Wu, Huangan, Pan, Yuncui, Wang, Qian, Zhang, Shuhui, Yang, Fan, Li, Jianwei, Liu, Guangyu, Xue, Xiaohong, Ji, Yajie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8913135/
https://www.ncbi.nlm.nih.gov/pubmed/35451408
http://dx.doi.org/10.1097/MD.0000000000029031
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author Zhang, Xinyue
Hu, Minhao
Li, Siyu
Sha, Shanyan
Mao, Ruoyu
Liu, Yu
Li, Qiong
Lu, Qing
Chen, Weili
Zhang, Ying
Wang, Rong
Xu, Huaijin
Wang, Jieqiong
Qiao, Yu
Chen, Ziyi
Wu, Huangan
Pan, Yuncui
Wang, Qian
Zhang, Shuhui
Yang, Fan
Li, Jianwei
Liu, Guangyu
Xue, Xiaohong
Ji, Yajie
author_facet Zhang, Xinyue
Hu, Minhao
Li, Siyu
Sha, Shanyan
Mao, Ruoyu
Liu, Yu
Li, Qiong
Lu, Qing
Chen, Weili
Zhang, Ying
Wang, Rong
Xu, Huaijin
Wang, Jieqiong
Qiao, Yu
Chen, Ziyi
Wu, Huangan
Pan, Yuncui
Wang, Qian
Zhang, Shuhui
Yang, Fan
Li, Jianwei
Liu, Guangyu
Xue, Xiaohong
Ji, Yajie
author_sort Zhang, Xinyue
collection PubMed
description INTRODUCTION: Neoadjuvant chemotherapy (NAC) plays an important role in downgrading preoperative tumor size, providing information on regimen activity, and increases treatment efficacy in breast cancer patients. An increasing number of patients have sought Traditional Chinese Medicine (TCM) during NAC to relieve discomfort, regulate immune function, and improve survival. However, limited evidence is available on how concurrent TCM treatment combined with NAC affects tumor response. This study aims to assess the efficacy of Yanghe decoction, a classical warming Yang formula, on pathological complete response (pCR) and explore its mechanism via the phosphatidylinositol-3-kinase/ protein kinase B/nuclear factor kappa-B (PI3K/Akt/NF-κB) pathway-mediated immune-inflammation microenvironment. METHODS: A single-center, randomized, placebo-controlled, double-blinded randomized control trial (RCT) was designed. This trial aims to recruit 128 participants with breast cancer scheduled to receive NAC in China. All participants will be randomly assigned (1:1) to the Neo-Yanghe group (Yanghe decoction plus NAC) or the control group (placebo plus NAC). The primary outcome will be evaluated by the proportion of participants achieving pCR. The secondary outcomes include the expression level of PI3K/Akt/NF-κB pathway-related proteins, the objective response rate, the time to response, serum level of immune-inflammatory indicators, quality of life, disease-free survival, and overall survival. DISCUSSION: This study will be the first RCT to evaluate the efficacy of Yanghe decoction combined with NAC in treating breast cancer patients, and elucidate the antitumor mechanism via the PI3K/Akt/NF-κB pathway-mediated immune-inflammation microenvironment. If possible, Neo-Yanghe treatment pattern will be a better pharmacological intervention to manage breast cancer than chemotherapy alone. The results of the trial will provide research-based evidence for the development of integrated Chinese and Western medicine guidelines and expert consensus. Trial registration: Chinese Clinical Trial Registry ChiCTR-INR-2000036943. Registered on September 28, 2020 (https://www.chictr.org.cn/hvshowproject.aspx?id=57141).
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spelling pubmed-89131352022-03-15 Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients Zhang, Xinyue Hu, Minhao Li, Siyu Sha, Shanyan Mao, Ruoyu Liu, Yu Li, Qiong Lu, Qing Chen, Weili Zhang, Ying Wang, Rong Xu, Huaijin Wang, Jieqiong Qiao, Yu Chen, Ziyi Wu, Huangan Pan, Yuncui Wang, Qian Zhang, Shuhui Yang, Fan Li, Jianwei Liu, Guangyu Xue, Xiaohong Ji, Yajie Medicine (Baltimore) 5750 INTRODUCTION: Neoadjuvant chemotherapy (NAC) plays an important role in downgrading preoperative tumor size, providing information on regimen activity, and increases treatment efficacy in breast cancer patients. An increasing number of patients have sought Traditional Chinese Medicine (TCM) during NAC to relieve discomfort, regulate immune function, and improve survival. However, limited evidence is available on how concurrent TCM treatment combined with NAC affects tumor response. This study aims to assess the efficacy of Yanghe decoction, a classical warming Yang formula, on pathological complete response (pCR) and explore its mechanism via the phosphatidylinositol-3-kinase/ protein kinase B/nuclear factor kappa-B (PI3K/Akt/NF-κB) pathway-mediated immune-inflammation microenvironment. METHODS: A single-center, randomized, placebo-controlled, double-blinded randomized control trial (RCT) was designed. This trial aims to recruit 128 participants with breast cancer scheduled to receive NAC in China. All participants will be randomly assigned (1:1) to the Neo-Yanghe group (Yanghe decoction plus NAC) or the control group (placebo plus NAC). The primary outcome will be evaluated by the proportion of participants achieving pCR. The secondary outcomes include the expression level of PI3K/Akt/NF-κB pathway-related proteins, the objective response rate, the time to response, serum level of immune-inflammatory indicators, quality of life, disease-free survival, and overall survival. DISCUSSION: This study will be the first RCT to evaluate the efficacy of Yanghe decoction combined with NAC in treating breast cancer patients, and elucidate the antitumor mechanism via the PI3K/Akt/NF-κB pathway-mediated immune-inflammation microenvironment. If possible, Neo-Yanghe treatment pattern will be a better pharmacological intervention to manage breast cancer than chemotherapy alone. The results of the trial will provide research-based evidence for the development of integrated Chinese and Western medicine guidelines and expert consensus. Trial registration: Chinese Clinical Trial Registry ChiCTR-INR-2000036943. Registered on September 28, 2020 (https://www.chictr.org.cn/hvshowproject.aspx?id=57141). Lippincott Williams & Wilkins 2022-03-11 /pmc/articles/PMC8913135/ /pubmed/35451408 http://dx.doi.org/10.1097/MD.0000000000029031 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/)
spellingShingle 5750
Zhang, Xinyue
Hu, Minhao
Li, Siyu
Sha, Shanyan
Mao, Ruoyu
Liu, Yu
Li, Qiong
Lu, Qing
Chen, Weili
Zhang, Ying
Wang, Rong
Xu, Huaijin
Wang, Jieqiong
Qiao, Yu
Chen, Ziyi
Wu, Huangan
Pan, Yuncui
Wang, Qian
Zhang, Shuhui
Yang, Fan
Li, Jianwei
Liu, Guangyu
Xue, Xiaohong
Ji, Yajie
Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title_full Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title_fullStr Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title_full_unstemmed Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title_short Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
title_sort clinical study on yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients
topic 5750
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8913135/
https://www.ncbi.nlm.nih.gov/pubmed/35451408
http://dx.doi.org/10.1097/MD.0000000000029031
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