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

  • 2022-03-11
  • Medicine 101(10)
    • Xinyue Zhang
    • Minhao Hu
    • Siyu Li
    • Shanyan Sha
    • Ruoyu Mao
    • Yu Liu
    • Qiong Li
    • Qing Lu
    • Weili Chen
    • Ying Zhang
    • Rong Wang
    • Huaijin Xu
    • Jieqiong Wang
    • Yu Qiao
    • Ziyi Chen
    • Huangan Wu
    • Yuncui Pan
    • Qian Wang
    • Shuhui Zhang
    • Fan Yang
    • Jianwei Li
    • Guangyu Liu
    • Xiaohong Xue
    • Yajie Ji

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 128
Population
128 participants with breast cancer scheduled to receive NAC in China
Methods
Single-center, randomized, placebo-controlled, double-blinded RCT; Yanghe decoction plus NAC vs placebo plus NAC
Blinding
Double-blind
Funding
Unclear
  • Large Human Trial

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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