A randomized, controlled, double-blind, multicenter clinical study of Huangqi Guizhi Wuwu Tang granules for the treatment of peripheral neurotoxicity induced by oxaliplatin in colorectal cancer chemot

Phase 2

• Conditions: Peripheral neurotoxicity caused by oxaliplatin for colorectal cancer chemotherapy

• Registration Number: ITMCTR2100005444
• Lead Sponsor: Peng Cao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Those who meet all of the following criteria will be selected.
1. age: between 18 and 75 years, regardless of gender
2. patients with a diagnosis of colorectal cancer confirmed by pathological histological examination
3. patients receiving the oxaliplatin regimen for the first time and developing grade 1 peripheral neurotoxicity (patients did not develop peripheral neurotoxicity before receiving the CapeOX regimen for the first time).
4. routine blood: absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, hemoglobin = 90 g/L
5. liver function: ALT = 3 times the upper limit of normal (ULN), AST = 3 times the upper limit of normal (ULN), bilirubin = 1.5 times the upper limit of normal (ULN)
6. renal function: creatinine = 1.5 times the upper limit of normal (ULN).
7. normal blood calcium and magnesium.
8. no history of concomitant heart block or heart block.
9. no family history of genetic/familial neuropathy.
10. ability to take oral medications.
11. no alcohol addiction or dependence.
12. expected survival of = 6 months
13. patients who voluntarily sign a written informed consent form.

Exclusion Criteria

Exclusion is required if any of the following criteria are met.
1. hypersensitivity to platinum, fluorouracil and the composition of Huangqi Wuwu Tang
2. patients with brain metastases.
3. pre-existing neuropathic disease (e.g., diabetic peripheral neuropathy, VB12 deficiency, thyroid dysfunction, AIDS, post-surgical/post-traumatic neuropathy, etc.)
4. pre-existing neurodegenerative disease (e.g. Parkinson's, Alzheimer's, Huntington's) or neuromuscular disease (e.g. multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease), history of epilepsy
5. taking other drugs that induce neurotoxicity (e.g., vincristine, perphenazine, paclitaxel, docetaxel, cytarabine, thalidomide, bortezomib, carboplatin, cisplatin, or procarbazine) during the use of the CapeOX regimen.
6. treatment with any other investigational drug or participation in another clinical trial within 4 weeks prior to the first administration of the trial drug.
7. taking neuroprotective drugs (e.g., monoamine oxidase inhibitors, antidepressants, anticonvulsants, neurotrophic factors, vitamins, etc.) during the use of the CapeOX regimen
8. use of digitalis analogues within 2 weeks.
9. uncontrolled infections.
10. pregnant or lactating women, or women of childbearing age with positive pregnancy test results; male or female patients who are not using effective contraception or who plan to conceive (inseminate) within 6 months of the start of the trial
11. other patients who, in the opinion of the investigator, are not suitable for enrollment.

Study & Design

• Study Type: Treatment study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to onset, incidence of grade 2 and grade 3 neurotoxicity;

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS);Quality of life assessments;Incidence of Adverse Events;Change from baseline in the EORTC-QLQ-CIPN20 scale and the EORTC QLQ-C30 scale;Chemotherapy effective rate (ORR): ORR=(CR+PR)/total number of cases×100%;Serum NGF concentrations;