Oncology
Conditions
Interventions
control group:All patients should not use drugs that may affect neurological symptoms during chemotherapy and ask for strict cold avoidance.
experimental group:From the first cycle of chemotherapy, oral methylcobalamin tablets (Mikobao)500 ug , orally, tid, 1 to 14 days and 21 days for 1 cycle.
Sponsors
Guangzhou Zengcheng District People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years, good cognitive ability; 2.Phase II confirmed by cytology or histology (high risk factors for recurrence including grade 3-4 tumor differentiation, lymphatic/vascular invasion, intestinal obstruction, detection of lymph node = 3.0 x 10^9, neutrophil cell count >= 1.5 x 10^9, hemoglobin >= 90, platelet >= 75, alanine aminotransferase and aspartate aminotransferase <= 2.5 times the upper limit of normal value, bilirubin <= 1.5 times the upper limit of normal value, creatinine <= 1.5 times the upper limit of normal value; 5.Nerve conduction velocity is normal before chemotherapy; 6.Patients can accurately record the occurrence and severity of neurotoxicity on questionnaires; 7.Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1.Chemotherapy after liver or lung metastasis resection in patients with colorectal cancer; 2.Palliative chemotherapy for colorectal cancer patients; 3.Patients with colorectal cancer need adjuvant or palliative radiotherapy during chemotherapy; 4.Patients with peripheral neuropathy or associated symptoms and who are receiving appropriate treatment; 5.Patients with diabetes, alcoholic diseases and neuropathy; 6.Be unable to conduct self-assessment due to mental disorders; 7.Patients who use drugs that cause neuropathy before or during chemotherapy, such as oxaliplatin, cisplatin, yew drugs, vinblastine drugs and so on; 8.Pregnant or lactating women, allergic constitution; 9.Severe cardiovascular, liver, and renal disease with other serious disease or condition, including uncontrolled active infection, severe diarrhea, severe electrolyte disturbance, active disseminated intravascular coagulation, and marked bleeding tendency; 10.In the investigator's judgment, there are serious comorbidities that compromised patient safety or prevented patients from completing the study; 11.Patients or family members are unable to understand the conditions and objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or above peripheral neuropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from study to onset of grade 2 or above peripheral neuropathy;Effects on long-term prognosis of tumors; | — |
Countries
China
Contacts
Public ContactHe Wenguang
Guangzhou Zengcheng District People's Hospital
Outcome results
None listed