Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

NCT04261920 | Unknown Phase 4 DMC

• 1 other identifier: FM-P8-2018060101
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Oncology

Keywords

Oxaliplatin induced peripheral neurotoxicity; Clinical curative effect

Outcome Measures

Primary Outcomes (1)

• incidence of chronic neurotoxicity

  Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment

  3 years

Secondary Outcomes (7)

• incidence of acute neurotoxicity

  3 years

• Time of occurrence of chronic toxicity

  3 years

• main symptoms

  3 years

• Recovery time of neurotoxicity

  3 years

• Cumulative dose of oxaliplatin and the proportion of patients

  3 years

Study Arms (2)

Single decoction group: Huangqi Guizhi Wuwu decoction

EXPERIMENTAL

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

Simulator group: Huangqi Guizhi Wuwu decoction Placebo

PLACEBO COMPARATOR

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

Interventions

Huangqi Guizhi Wuwu decoction 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).

Also known as: Huangqi Guizhi Wuwu decoction placebo

Simulator group: Huangqi Guizhi Wuwu decoction Placebo; Single decoction group: Huangqi Guizhi Wuwu decoction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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.
• 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.
• \. The patient who will sign the informed consent form

You may not qualify if:

• Patients with original nervous system diseases, including peripheral neuropathy and central neuropathy;
• Those who are allergic to oxaliplatin or the ingredients of this traditional Chinese medicine;
• 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;
• Patients with neurological disease caused by electrolyte disorders or diabetes;
• Patients with symptoms of nerve compression caused by various causes;
• At the same time, patients who receive other neuroprotective therapy, including nerve growth factor, vitamin B and calcium-magnesium mixture;
• Patients who were treated with oxaliplatin for chemotherapy before;
• Patients who need radiotherapy within half a year after operation;
• Pregnant or lactation period women;
• Patients with cognitive impairment or psychosis;

Sponsors & Collaborators

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

Study Sites (2)

Affiliated Hospital of Nanjing University of TCM

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32481364 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Chen Haibo, PhD

CONTACT

86-025-85811005; hbcheng@njucm.edu.cn

Gu Yanhong, PhD

CONTACT

86-13813908678

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: January 3, 2020
• Primary Completion: January 2, 2023
• Study Completion: March 2, 2023
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

CN (2)