Clinical study on acupuncture in the treatment of oxaliplatin-induced peripheral neurotoxicity

Hospital of Chengdu University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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 <= 80 years, regardless of gender;
•6. ECOG PS score 0-2, and life expectancy >= 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 <= 15 x 10^9 /L;
•(2) The absolute value of neutrophil count (ANC) >= 1.5 x 10^9 /L;
•(3) Hemoglobin (Hb) >= 80 g/L;
•(4) Platelet count (PLT) >= 70 x 10^9 /L;
•(5) APTT <= 1.5 times of upper limits of normal (ULN) and INR or PT <= 1.5 times of ULN (no anticoagulation treatment);
•(6) AST and ALT <= 1.5 times of ULN (if there is tumor liver metastasis, < 5 times of ULN);
•(7) TBIL <= 1.5 times of ULN;
•(8) Cr <= 1.5 times of ULN, and CrCl >= 60 ml / min (Cockcroft Gault formula);
•8. Those who fully understand this study and voluntarily sign the informed consent form, with good compliance.

•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.

发起方

Hospital of Chengdu University of Traditional Chinese Medicine