Effects of External Application of Traditional Chinese Medicine Hexue Tongbi Powder on Oxaliplatin-Induced Peripheral Neuropathy Among Patients With Colorectal Cancer: an Open-Label, Randomized Controlled Trial

Phase 1

• Conditions: Colorectal cancer

• Registration Number: ITMCTR2000003307
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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

1. When the subjects signed the informed consent, they were >= 18 years old, both male and female;
2. Patients with colorectal cancer confirmed by histology or cytology;
3. Patients who have not received oxaliplatin before;
4. Patients with ECoG PS 0-2;
5. Patients with life expectancy >= 3 months;
6. Patients who are willing to comply with the requirements of informed consent can use drugs according to the doctor's orders and receive regular follow-up,;
7. Patients who can complete the questionnaire by themselves or with assistance;
8. Patients who are in line with the indications of chemotherapy and intend to receive oxaliplatin chemotherapy;
9. Blood analysis and examination: (no blood transfusion, no use of G-CSF, no use of drug correction within 14 days before screening);
(1) Hemoglobin (HB) >= 90 g / L;
(2) The absolute value of neutrophil count (ANC) >= 1.5 x 10^9 / L;
(3) Platelet count (PLT) >= 100 x 10^9 / L;
(4) WBC >= 4.0 x 10^9 / L and <= 15 x 10^9 / L.
10. Biochemical examination: (no blood transfusion or albumin within 14 days before screening);
(1) AST and alt <= 1.5 times of upper limits of normal (ULN) (if there is tumor liver metastasis, < 5 times of ULN);
(2) ALP <= 2.5 times ULN (in case of tumor bone metastasis, < 5 times ULN);
(3) TBIL <= 1.5 times ULN;
(4) ALB >= 30g/L;
(5) Cr <= 1.5 times ULN, Cr Cl >= 60 ml / min (Cockcroft Gault formula);
(6) APTT <= 1.5 times ULN and INR or PT <= 1.5 times ULN (no anticoagulation treatment);
11. Women of childbearing age must be defined as not pregnant before the first medication. Women of childbearing age and male subjects with partners of women of childbearing age must agree to use effective contraceptive methods during the study and within 180 days after the last administration of the study drug.

Exclusion Criteria

1. Patients with other neuropathy;
2. Diabetic patients with bone and joint diseases and peripheral sensory abnormalities;
3. Patients with peripheral neuropathy caused by poisoning, infection, radiotherapy, etc;
4. Patients with other skin diseases;
5. Patients who need to receive other drugs that may change the symptoms of peripheral nervous system during the treatment;
6. Patients with allergic constitution or allergy to related traditional Chinese medicine;
7. Subjects with mental illness, alcoholism, inability to quit smoking, drug use or drug abuse were excluded;
8. Subjects with any disease, treatment or laboratory history or current evidence that may confuse the results of the study, interfere with the subject's participation in the study procedure or not in the best interest of the subject's participation in the study are excluded according to the judgment of the investigator.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Incidence of peripheral neuropathy after 4 cycles of chemotherapy (CTCAE 5.0);

Secondary Outcome Measures

Name	Time	Method
Incidence of peripheral neuropathy after 4 cycles of chemotherapy (QLQ-CIPN20);Integration of peripheral neuropathy after chemotherapy (TNAS);