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

Phase 1

Recruiting

Conditions: Oxaliplatin-induced peripheral neurotoxicity

Registration Number: ITMCTR2100004219

Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

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 <= 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.

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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-CIPN 20;Total Neuropathy Score-clinical version (TNSc);NCI-CTCAE (v5.0);

Secondary Outcome Measures

Name	Time	Method
KPS;EORTC QLQ-C30;NPS;Safety index, such as blood routine, urine routine, stool routine, coagulation function, liver function, renal function, electrocardiogram, etc.;