Oxaliplatin induced peripheral neurotoxicity
Conditions
Interventions
Treatment group:After the initiation of adjuvant chemotherapy (the chemotherapy regimen includes XELOX and mFOLFOX6) take a dose of Shuangjinlong decoction formula granulaon orally once a day until th
Control group:After the initiation of adjuvant chemotherapy (the chemotherapy regimen includes XELOX and mFOLFOX6), take a dose of Shuangjinlong herbal decoction orally once a day, until the end of th
Sponsors
Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Before registering for this study patients must meet all of the following criteria: 1. The selected cases must meet the diagnostic criteria for colorectal cancer in the "Diagnosis and Treatment Specifications for Common Malignant Tumors in China" issued by the National Health Commission of the People's Republic of China and must be confirmed by pathological data. 2. They must be patients who have undergone radical resection for colorectal cancer and received adjuvant chemotherapy (excluding patients with middle and low rectal cancer). 3. The age should be between 18 and 75 years old. 4. The Karnofsky performance status score should be above 60 and the expected survival period should be more than 6 months. 5. There should be no other underlying diseases that affect organ function. 6. Obtain the complete written informed consent from the patients.
Exclusion criteria
Exclusion criteria: The following patients are excluded: 1. Patients with multiple confirmed malignant tumors (repeated cancers). 2. Patients with any level of neuropathy especially peripheral neuropathy. 3. Patients who received drugs that could cause CIPN within 3 months prior to enrollment such as oxaliplatin cisplatin taxanes vinblastine apatinib etc. 4. Patients with second or third degree atrioventricular block. 5. Patients currently taking carbamazepine phenytoin valproic acid gabapentin pregabalin venlafaxine desvenlafaxine mianserin duloxetine tricyclic antidepressants. 6. Pregnant or lactating women. 7. Patients with mental disorders. 8. Patients with other diseases that may affect the patient's survival period such as coronary heart disease myocardial infarction renal failure pulmonary embolism etc. 9. Diabetic patients. 10. Patients requiring radiotherapy. 11. Patients with poor compliance and inability to cooperate with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensory nerve conduction velocity and motor nerve conduction velocity ;The relative expression levels of TLR4 mRNA and NF-?B mRNA in peripheral blood;Levels of inflammatory factors IL-1ß, IL-6, and TNF-a in peripheral blood;Evaluation of peripheral nerve toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky Performance Status Score;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30; | — |
Countries
China
Contacts
Public ContactHuatang Zhang
Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed