Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial

To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.

Study Overview

• Status: Recruiting
• Conditions: Oncology
• Intervention / Treatment: Drug: Huangqi Guizhi Wuwu decoction

Detailed Description

The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gu Yanhong, PhD; Phone Number: 86-13813908678

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Gu Yanhong, PhD; Phone Number: 86-13813908678
      • Contact: Chen Xiaofeng, PhD
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • Affiliated Hospital of Nanjing University of TCM
      • Contact: Shu Peng, PhD; Phone Number: 86-13851701678

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage (according to CSCO guidelines for diagnosis and treatment of colorectal cancer) or III stage, IV stage (metastatic lesions have been radical resection); 2. Patients who are suitable for receiving oxaliplatin plus capecitabine regimen as adjuvant chemotherapy for 6 months, the cumulative dose of oxaliplatin are expected to exceed 520mg/m2 at least; 3. Aged from 18 to 75 years old, males or females; 4. ECOG score ranges from 0 to 1 5. Seven days before treatment, the functions of major organs (heart, liver, kidney, bone marrow) meet the following criteria:

1. Standard of blood routine examination (without blood transfusion within 14 days) i. Hemoglobin (HB) ≥90g/L； ii. Absolute Neutrophil Count(ANC) ≥1.5×109/L；. iii. Platelet (PLT) ≥80×109/L.

2. Biochemical examination should meet the following standards:

   • Total bilirubin(TBIL) ≤1.5 times upper normal limit(ULN);

     • Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) ≤2.5 times ULN；

       ③Serum creatinine （Cr）≤1.5 times ULN or Creatinine clearance(CCr) ≥60ml/min; 6.Expected survival time≥12 months; 7. For subjects who have used other chemotherapeutic drugs in the past, they need to go through a clearance period of at least 4 weeks before entering this trial.

       8. The patient who will sign the informed consent form

Exclusion Criteria:

1. Patients with original nervous system diseases, including peripheral neuropathy and central neuropathy;
2. Those who are allergic to oxaliplatin or the ingredients of this traditional Chinese medicine;
3. Clinical symptoms of patients with severe damp-heat syndrome of colorectal cancer include: dry mouth, bitter taste in the mouth, sticky sensation in mouth, yellow urine, dry stool, red tongue with yellow ,thick and greasy fur;
4. Patients with neurological disease caused by electrolyte disorders or diabetes;
5. Patients with symptoms of nerve compression caused by various causes;
6. At the same time, patients who receive other neuroprotective therapy, including nerve growth factor, vitamin B and calcium-magnesium mixture;
7. Patients who were treated with oxaliplatin for chemotherapy before;
8. Patients who need radiotherapy within half a year after operation;
9. Pregnant or lactation period women;
10. Patients with cognitive impairment or psychosis;
11. Other patients the investigator considers unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single decoction group: Huangqi Guizhi Wuwu decoction; The dosage of granules: Sheng huangqi granule 5.5g/bag, Guizhi granule 0.9g/bag, Baishao granule 1.6g/bag, Ganjiang granule 1.7g/bag, Dazao granule 7g/bag. Take twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)	Drug: Huangqi Guizhi Wuwu decoction; The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).; Other Names: Huangqi Guizhi Wuwu decoction placebo
Placebo Comparator: Simulator group: Huangqi Guizhi Wuwu decoction Placebo; The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)	Drug: Huangqi Guizhi Wuwu decoction; The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).; Other Names: Huangqi Guizhi Wuwu decoction placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of chronic neurotoxicity	Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of acute neurotoxicity	Difference in the incidence of acute neurotoxicity	3 years
Time of occurrence of chronic toxicity	Time of occurrence of chronic toxicity to grade 2 and 3	3 years
main symptoms	Incidence and severity of main symptoms	3 years
Recovery time of neurotoxicity	Recovery time of grade 2 and 3 neurotoxicity	3 years
Cumulative dose of oxaliplatin and the proportion of patients	Cumulative dose of oxaliplatin and the proportion of patients who stop using oxaliplatin because of neurotoxicity	3 years
myelosuppression	Incidence of myelosuppression	3 years
nausea, vomiting, diarrhea, and hand-foot syndrome	Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome	3 years

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Publications and helpful links

General Publications

• Wei XM, Chen XF, Shu P, Jiang ZW, Wu XY, Zou X, Chen K, Shen B, Hu WW, Lu W, Shen WX, Li L, Wang JY, Zhao FJ, Yin QF, Cheng HB, Gu YH. Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial. Medicine (Baltimore). 2020 May 29;99(22):e19923. doi: 10.1097/MD.0000000000019923.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Anticipated): January 2, 2023
• Study Completion (Anticipated): March 2, 2023

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Oxaliplatin induced peripheral neurotoxicity; Clinical curative effect
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FM-P8-2018060101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No