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Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261920
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Oncology Drug: Huangqi Guizhi Wuwu decoction Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : January 2, 2023
Estimated Study Completion Date : March 2, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Huangqi Guizhi Wuwu decoction placebo




Primary Outcome Measures :
  1. incidence of chronic neurotoxicity [ Time Frame: 3 years ]
    Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment


Secondary Outcome Measures :
  1. incidence of acute neurotoxicity [ Time Frame: 3 years ]
    Difference in the incidence of acute neurotoxicity

  2. Time of occurrence of chronic toxicity [ Time Frame: 3 years ]
    Time of occurrence of chronic toxicity to grade 2 and 3

  3. main symptoms [ Time Frame: 3 years ]
    Incidence and severity of main symptoms

  4. Recovery time of neurotoxicity [ Time Frame: 3 years ]
    Recovery time of grade 2 and 3 neurotoxicity

  5. Cumulative dose of oxaliplatin and the proportion of patients [ Time Frame: 3 years ]
    Cumulative dose of oxaliplatin and the proportion of patients who stop using oxaliplatin because of neurotoxicity

  6. myelosuppression [ Time Frame: 3 years ]
    Incidence of myelosuppression

  7. nausea, vomiting, diarrhea, and hand-foot syndrome [ Time Frame: 3 years ]
    Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261920


Contacts
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Contact: Chen Haibo, PhD 86-025-85811005 hbcheng@njucm.edu.cn
Contact: Gu Yanhong, PhD 86-13813908678

Locations
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China, Jiangsu
Affiliated Hospital of Nanjing University of TCM Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Shu Peng, PhD    86-13851701678      
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Gu Yanhong, PhD    86-13813908678      
Contact: Chen Xiaofeng, PhD         
Sponsors and Collaborators
Jiangsu Famous Medical Technology Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04261920    
Other Study ID Numbers: FM-P8-2018060101
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Famous Medical Technology Co., Ltd.:
Oxaliplatin induced peripheral neurotoxicity
Clinical curative effect
Additional relevant MeSH terms:
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Neoplasms