Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

NCT ID: NCT04261920

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2023-03-02

Brief Summary

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

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.

Conditions

Oncology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Huangqi Guizhi Wuwu decoction

Intervention Type: DRUG

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).

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)

Group Type: PLACEBO_COMPARATOR

Huangqi Guizhi Wuwu decoction

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Huangqi Guizhi Wuwu decoction placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Famous Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Nanjing University of TCM

Nanjing, Jiangsu, China

Site Status: NOT_YET_RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Haibo, PhD

Role: CONTACT

hbcheng@njucm.edu.cn

86-025-85811005

Gu Yanhong, PhD

Role: CONTACT

86-13813908678

Facility Contacts

Shu Peng, PhD

Role: primary

86-13851701678

Gu Yanhong, PhD

Role: primary

86-13813908678

Chen Xiaofeng, PhD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 32481364 (View on PubMed)

Other Identifiers

FM-P8-2018060101

Identifier Type: -

Identifier Source: org_study_id