Clinical trial NCT04261920: Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oncology
Keywords: Oxaliplatin induced peripheral neurotoxicity
Clinical curative effect
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence of chronic neurotoxicity
timeFrame: 3 years
Secondary outcomes:
measure: incidence of acute neurotoxicity
timeFrame: 3 years
measure: Time of occurrence of chronic toxicity
timeFrame: 3 years
measure: main symptoms
timeFrame: 3 years
measure: Recovery time of neurotoxicity
timeFrame: 3 years
measure: Cumulative dose of oxaliplatin and the proportion of patients
timeFrame: 3 years
measure: myelosuppression
timeFrame: 3 years
measure: nausea, vomiting, diarrhea, and hand-foot syndrome
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of TCM
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
citation: 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.