Preventive Efficacy and Safety of Yiqi-Wenjing-Fang Granules on Oxaliplatin-Induced Peripheral Neuropathy: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Zhancheng Gu, Guoli Wei, Liangjun Zhu, Lingjun Zhu, Jing Hu, Qi Li, Guoxiang Cai, Hong Lu, Min Liu, Chen Chen, Yi Ji, Guochun Li, Jiege Huo, Zhancheng Gu, Guoli Wei, Liangjun Zhu, Lingjun Zhu, Jing Hu, Qi Li, Guoxiang Cai, Hong Lu, Min Liu, Chen Chen, Yi Ji, Guochun Li, Jiege Huo

Abstract

Background. Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most common side effects of oxaliplatin, which can cause reduction and cessation of oxaliplatin-based chemotherapy and significantly affect patients' quality of life. However, no drug has got recognition to prevent or treat OIPN. Yiqi-Wenjing-Fang (YWF) is a joint name of Chinese medicine prescriptions with similar effects of tonifying qi and warming meridians, represented by Huangqi Guizhi Wuwu decoction (HGWD) and Danggui Sini decoction (DSD), both from "Treatise on Cold Pathogenic and Miscellaneous Diseases." YWF granules, including HGWD granules and DSD granules, have been, respectively, demonstrated to be effective in preventing OIPN in previous small-sample observations. The purpose of this study is to enlarge the sample size for further evaluation of the preventive efficacy and safety of YWF granules on OIPN. Methods and Analysis. This study is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. 360 postoperative patients with stage IIa-IIIc colorectal cancer will be randomly assigned into placebo-control group, intervention group I, and intervention group II, taking the mimetic granules of YWF as placebo, HGWD granules and DSD granules, respectively. All subjects will receive oxaliplatin-based chemotherapy regimen at the same time. EORTC QLQ-CIPN20 will be used to assess the degree of OIPN as the primary outcome measure. The grades of OIPN, quality of life, chemotherapeutic efficacy, and the number of completed chemotherapy cycles are selected as the secondary outcome measures. Discussion. Based on the condition of no recognized effective drugs in preventing OIPN, evidence-based medical study will be conducted for seeking a breakthrough in the field of Chinese herb medicine. This protocol could provide reliable and systemic research basis about the efficacy of YWF granules and the differentiation of two classical prescriptions of YWF on preventing OIPN objectively. Trial Registration. This study was registered at ClinicalTrials.gov on 26 December 2020 (ID: https://ichgcp.net/clinical-trials-registry/NCT04690283).

Conflict of interest statement

The authors declare that they have no conflicts of interest regarding the publication of this paper.

Copyright © 2021 Zhancheng Gu et al.

Figures

Figure 1
Figure 1
Study flow chart of enrollment, allocation, intervention, and assessment.
Figure 2
Figure 2
Schedule of enrollment, allocation, intervention, and assessment. Note. Subjects will complete the EORTC QLQ-CIPN20 questionnaire for 4 consecutive times during cycle 1 (refer to 2.8). EORTC QLQ-CIPN20: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale; NCI-CTCAE 5.0: National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0; EORTC QLQ-C30: European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire; RECIST 1.1: Response Evaluation Criteria in Solid Tumors Version 1.1.

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