Oxaliplatin-induced peripheral neurotoxicity
Conditions
Interventions
experimental group:acupuncture
control group:sham acupuncture
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage III-IV colon cancer confirmed by pathology or cytology; 2. Patients who received oxaliplatin chemotherapy for less than or equal to 2 cycles within 3 months before enrollment, and had peripheral neuropathy; 3. Patients with peripheral neurotoxicity of grade 2 or higher assessed according to the NCI-CTCAE (v5.0) classification of peripheral neurotoxicity; 4. Plan to continue to receive oxaliplatin chemotherapy for at least 4 cycles; 5. Aged >= 18 and = 12 weeks; 7. The function of bone marrow, heart, liver, kidney and other organs is basically normal, meeting the following standards: (1) WBC >= 4.0 x 10^9 /L and = 1.5 x 10^9 /L; (3) Hemoglobin (Hb) >= 80 g/L; (4) Platelet count (PLT) >= 70 x 10^9 /L; (5) APTT = 60 ml / min (Cockcroft Gault formula); 8. Those who fully understand this study and voluntarily sign the informed consent form, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Previously received other drugs that may cause neurotoxicity except oxaliplatin, such as cisplatin, carboplatin, paclitaxel, docetaxel, thalidomide, procarbazide, cytarabine, bortezomib, etoposide, etc.; 2. Patients with neuropathy or peripheral sensory abnormality caused by other reasons, such as diabetes, tumor craniocerebral metastasis, severe electrolyte disorder, severe cervical spondylosis, etc.; 3. Received acupuncture treatment within 3 months before enrollment, or have used drugs for the treatment of neuropathic pain, such as carbazepine, phenytoin sodium, valproate sodium, gabapentin, pregabalin, venlafaxine, duloxetine, tricyclic antidepressants, etc.; 4. Patients combined with uncontrolled active infection and serious diseases of the heart, brain, liver, kidney and blood system; 5. Patients with pacemaker or defibrillator implants; 6. Those who afraid of needles or fainting during acupuncture treatment; 7. Women who are pregnant or breastfeeding, including those of childbearing age who are unwilling to use contraception; 8. Patients with cognitive impairment or mental disorders; 9. Patients with severe skin lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EORTC QLQ-CIPN 20;Total Neuropathy Score-clinical version (TNSc);NCI-CTCAE (v5.0); | — |
Secondary
| Measure | Time frame |
|---|---|
| KPS;EORTC QLQ-C30;NPS;Safety index, such as blood routine, urine routine, stool routine, coagulation function, liver function, renal function, electrocardiogram, etc.; | — |
Countries
China
Contacts
Public ContactZhuohong Li
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed