A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study on the Effectiveness and Safety of Zhengyuan Capsules for Cancer-related Fatigue in Patients With Breast Cancer

Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.

Start Date01 May 2024

Sponsor / Collaborator

Jiangsu Yangtze River Pharmaceutical Group Co., Ltd.

CTR20220743 / RecruitingPhase 2

正元胶囊治疗化疗相关性癌因性疲乏有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial on the efficacy and safety of Zhengyuan Capsule in the treatment of chemotherapy-related cancer fatigue

主要目的：评价正元胶囊治疗化疗相关性癌因性疲乏有效性和安全性；次要目的：评价正元胶囊对患者生存质量的影响；探索免疫功能指标、神经内分泌功能指标与癌因性疲乏及正元胶囊的关系。

[Translation]

Main purpose: To evaluate the effectiveness and safety of Zhengyuan capsule in the treatment of chemotherapy-related cancer-related fatigue; Secondary purpose: To evaluate the effect of Zhengyuan capsule on the quality of life of patients; To explore the relationship between immune function indicators, neuroendocrine function indicators, cancer-related fatigue and Zhengyuan capsule.

Start Date11 May 2022

Sponsor / Collaborator

Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhengyuan Capsule

100 Translational Medicine associated with Zhengyuan Capsule

100 Patents (Medical) associated with Zhengyuan Capsule

Literatures (Medical) associated with Zhengyuan Capsule

01 Nov 2022·Journal of Thoracic Disease

Zhengyuan capsules for the treatment of chemotherapy-induced cancer-related fatigue in stage IIIB–IV unresectable NSCLC: study protocol for a randomized, multi-center, double-blind, placebo-controlled clinical trial

Article

Author: Qi, Xiangjun ; Yang, Ting ; Zheng, Xinting ; Chen, Wenmin ; Chen, Hanrui ; Sun, Lingling ; Cao, Yang ; Lin, Lizhu ; Lin, Jietao

BackgroundPatients with advanced non-small cell lung cancer (NSCLC) frequently experience cancer-related fatigue (CRF) during or after chemotherapy. Traditional Chinese medicine (TCM) can effectively relieve CRF, although the clinical evidence is insufficient due to the absence of extensive and rigorous clinical studies. Zhengyuan capsules have both tonifying and dispersing effects, and its ability to alleviate CRF has been verified in mice. This study aimed to provide evidence for the role of proprietary Chinese medicines in alleviating CRF in advanced NSCLC patients.MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial has been designed to evaluate the efficacy and safety of Zhengyuan capsules for CRF in stage IIIB-IV unresectable NSCLC patients undergoing chemotherapy. Thirty eligible participants will be randomized into two groups at a 1:1 ratio during chemotherapy using the centralized interactive web response system. All patients will receive conventional platinum-based dual-drug chemotherapy and Zhengyuan capsules or simulant for 42 consecutive days starting on the first day of the first week of chemotherapy. The primary outcome is the difference between baseline and post-treatment CRF in the two groups, which will be assessed using the Brief Fatigue Inventory (BFI) score. Secondary outcome measurements include the Revised Piper's Fatigue Scale (RPFS)-Chinese Version, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Module C30 (EORTC QLQ-C30) v3.0 combined with EORTC QLQ-LC13 (Lung Cancer 13), clinical symptom score, hematology exploratory index, and progression-free survival. And safety indicators such as blood, urine, fecal routine, liver and kidney function, coagulation, and electrocardiogram will be performed before chemotherapy. Data will be analyzed according to intention-to-treat (ITT) and per-protocol (PP) principles; Empowerstats and R will be applied for statistical analysis.DiscussionThis trial will provide data on the efficacy and safety of Zhengyuan capsules for treating CRF in stage IIIB-IV unresectable NSCLC patients undergoing chemotherapy. It will also provide a basis for the feasibility of a large-scale clinical trial.Trial RegistrationThe clinical trial was registered on 19 November 2020 through https://www.chictr.org.cn (registration number: ChiCTR2000040061).

23 May 2022·Evidence-Based Complementary and Alternative Medicine

Clinical Observation of Zhengyuan Capsule Combined with Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer

Article

Author: Li, Huixin ; Zhang, Hengle ; Wang, Zunyi ; Zhang, Xiaoyu ; Kang, Xiaoning ; Sun, Dan ; Jin, Lijun ; Wu, Feng

Objective. To study the clinical effect of Zhengyuan capsule combined with neoadjuvant chemotherapy in the treatment of triple-negative breast cancer (TNBC). Methods. From September 2014 to September 2017, 120 TNBC patients who underwent radical mastectomy in our hospital were randomly divided into control group (n = 60) and observation group (n = 60). The short-term curative effect, the incidence of toxicity and side effects, and the score of quality of life of the patients were compared. Both recurrence and metastasis rates were also analyzed. Results. The combined treatment of Zhengyuan capsule with neoadjuvant chemotherapy significantly improved the objective remission rate (70.00% in the observation group versus 40.00% in the control group) (

P < 0.05

). Moreover, this combined treatment significantly decreased the total incidence of side effects (35.00% versus 75.00%). Accordingly, the score of quality of life was also increased in patients treated with Zhengyuan capsule plus neoadjuvant chemotherapy (

P < 0.05

). Furthermore, supplementation of Zhengyuan capsule can significantly suppress both the recurrence and metastasis rate of TNBC in patients treated with neoadjuvant chemotherapy after radical mastectomy in following 3 years (30.00% versus 10.00%,

P < 0.05

). Conclusion. Zhengyuan capsule effectively improves the short-term curative effect, reduces the side effects of chemotherapy, and improves the quality of life of patients treated with neoadjuvant chemotherapy after radical mastectomy. More importantly, this combined treatment can also reduce the long-term recurrence and metastasis of TNBC.

01 Aug 2021·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Zhengyuan capsule for the treatment of cancer-related fatigue in lung cancer patients undergoing operation: a study protocol for a randomized controlled trial.

Review

Author: Mona, Pazhouhi ; Mohammad, Zamanian ; Mohsen, Akbaribazm ; Mozafar, Khazaei ; Fatemeh, Khazaei ; Leila, Naseri

OBJECTIVETo evaluate the efficacy and safety of Zhengyuan capsule () when treating Cancer-related fatigue (CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGNThis 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-α, 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).DISCUSSIONThe 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.

100 Deals associated with Zhengyuan Capsule

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Indication	Country/Location	Organization	Date
Fatigue	CN	Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.	20 Mar 2014

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