Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261920
• Other study ID #: FM-P8-2018060101
• Status: Recruiting
• Phase: Phase 4
• Start date: January 3, 2020
• Est. completion date: March 2, 2023

Study information

• Verified date: March 2020
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Chen Haibo, PhD
• Phone: 86-025-85811005
• Email: hbcheng[@]njucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

?Serum 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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

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).

Locations

Country	Name	City	State
China	Affiliated Hospital of Nanjing University of TCM	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of chronic neurotoxicity	Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment	3 years
Secondary	incidence of acute neurotoxicity	Difference in the incidence of acute neurotoxicity	3 years
Secondary	Time of occurrence of chronic toxicity	Time of occurrence of chronic toxicity to grade 2 and 3	3 years
Secondary	main symptoms	Incidence and severity of main symptoms	3 years
Secondary	Recovery time of neurotoxicity	Recovery time of grade 2 and 3 neurotoxicity	3 years
Secondary	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
Secondary	myelosuppression	Incidence of myelosuppression	3 years
Secondary	nausea, vomiting, diarrhea, and hand-foot syndrome	Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome	3 years