Overview

Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

Status:
Recruiting

Trial end date:
2023-03-02

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jiangsu Famous Medical Technology Co., Ltd.

Treatments:

Oxaliplatin

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.