CIPN
Conditions
Interventions
Group A (Control Group):Provide routine care. For patients diagnosed with CIPN during chemotherapy and whose severity is = grade 2, follow the clinical routine treatment procedures.
Group B (The Experimental Group):On the basis of routine care, Omega-3 fatty acid ethyl ester 90 soft capsules and levocarnitine oral solution are administered.
Omega-3 fatty acid ethyl ester 90 soft
Dosage and administration method: 2 capsules each time, twice a day
or 1 capsule each time, once a day, after meals.
Levocarnitine oral solution (Levocarnitine Oral Solution, Dongweili) (Shenyang First Pharmaceutical Co., Ltd., Northeast Pharmaceutical Group): Specifi
Dosage and administration method: 1 bottle each time, 3 times a day, during meals.
Note: Adjusting the dosage of chemotherapy and intervention drugs based on the patients clinical condition does not c
Sponsors
Jiangsu Hengrui Medicine Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years inclusive. 2. Patients with colorectal cancer who, following radical surgical resection, have been histologically confirmed as high-risk stage II or III requiring adjuvant chemotherapy (as defined below). Patients must have undergone radical surgery (R0 resection), with postoperative pathological confirmation of adenocarcinoma, and meet the following American Joint Committee on Cancer (AJCC) 9th Edition staging criteria for colorectal cancer: High-risk Stage II: Meeting at least one of the following risk factors: T4 stage (T4a or T4b); poor histological grade (poorly differentiated or undifferentiated); Positive lymphovascular invasion (LVI) or perineural invasion (PNI); intestinal obstruction or tumour perforation; positive, close, or uncertain surgical margins; <12 lymph nodes examined. Stage III: Any T stage with regional lymph node metastasis (N1 or N2) and no distant metastasis (M0). 3. ECOG performance status = 1. 4. Planned to receive oxaliplatin-based adjuvant chemotherapy as the first post-operative regimen. Common oxaliplatin-containing chemotherapy regimens include: (1) mFOLFOX6 regimen: Oxaliplatin: 85 mg/m² intravenous infusion over 2 hours, Day 1; Calcium folinate: 400 mg/m² intravenous infusion over 2 hours, Day 1; 5-Fluorouracil: 400 mg/m² intravenous bolus on Day 1, followed by 1200 mg/(m²·d) × 2 continuous intravenous infusion (total dose 2400 mg/m², infusion over 46–48 hours); chemotherapy will be administered every 2 weeks for 12 cycles; (2) CAPEOX regimen: Oxaliplatin: 130 mg/m² intravenous infusion over 2 hours, Day 1; Capecitabine: 1000 mg/m² orally, twice daily, Days 1–14; Chemotherapy administered every 3 weeks for 8 cycles; (3) FOLFOXIRI regimen: Irinotecan: 165 mg/m², intravenous infusion, Day 1; Oxaliplatin: 85 mg/m², intravenous infusion, Day 1; Calcium folinate: 400 mg/m², intravenous infusion, Day 1; 5-Fluorouracil: Total 5-FU dose: 2400–3200 mg/m², intravenous infusion over 48 hours, Day 1; Chemotherapy will be administered every 2 weeks for 12 cycles. 5. Within 14 days prior to enrolment, based on the most recent laboratory test results, the following criteria must be met: Complete blood count: Neutrophil count (ANC) = 1.5 × 10?/L, Platelet count (PLT) = 100 × 10?/L, Haemoglobin (Hb) = 80 g/L; Liver function: Serum total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN), Alanine Transaminase (ALT) and Aspartate Transaminase (AST) = 2.5 × ULN; Renal Function: Creatinine Clearance (CCr) = 50 ml/min. 6. The patient's life expectancy should not be less than 3 months. 7. Voluntary signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing anti-neurotoxic treatment. 2. Patients with cardiac dysfunction: within 6 months before the first administration of the study drug, they had experienced myocardial infarction, uncontrolled angina pectoris, atrial fibrillation, need for medical treatment for arrhythmia (including pacemaker therapy), NYHA Class III or IV congestive heart failure, and cardiac echocardiography showing left ventricular ejection fraction (LVEF) 1.8; activated partial thromboplastin time (APTT) more than 1.5 times the upper limit of the normal value. 4. Patients receiving neurotoxic drugs or anti-neurotoxic drugs. 5. Peripheral or central nervous system abnormalities, including diabetic patients with mental disorders. 6. Comorbid with a second primary tumor. 7. Allergic to the components of the study drug or unable to take oral administration; pre-existing peripheral PN due to DM, HIV, alcohol abuse, thyroid dysfunction, vitamin deficiency, and hereditary PN-related diseases; BMI = 30. 8. Took any nutritional supplements (fish oil, vitamins, minerals, etc.) three months before enrollment. 9. Pregnant women, breastfeeding women, or those planning to get pregnant during the study period. 10. Have mental disorders or drug abuse conditions that may affect compliance with the trial requirements. 11. Participate in other interventional clinical studies (unless participating in observational studies or the subsequent stages of intervention studies). Other serious physical or mental diseases or laboratory test abnormalities may increase the risk of participating in the study. And situations where the investigator judges the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of CIPN;The severity of CIPN; | — |
Secondary
| Measure | Time frame |
|---|---|
| Living quality;Neuropathic pain;The changes in the relative dose intensity (RDI) of oxaliplatin caused by CIPN;Security analysis; | — |
Countries
China
Contacts
Public ContactLi Yong
The First Affiliated Hospital of Nanchang University
Outcome results
None listed