Neuroprotective Effect of Neurotropin on Chronic OXA-induced Neurotoxicity in Stage II and Stage III CRC Patients

Neuroprotective Effect of Neurotropin on Chronic Oxaliplatin-induced Neurotoxicity in Stage II and Stage III Colorectal Cancer Patients: a Randomized, Double-blind, Placebo-controlled, Parallel Grouping Multi-center Clinical Trial

Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.

Inclusion Criteria:

• 18 to 75 years old
• Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
• should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
• Agreed and assigned the consent, and was able to receive the baseline assessment
• Could be inpatient or outpatient participants

Exclusion Criteria:

• Peripheral neuropathy patients, e.g. diabetes neuropathy
• Alcoholic related patients
• Central neuropathy patients
• Patients who were unable to assess the effectivity and safety
• Neurotropin allergy
• History of medications that are contraindicated to neurotropin <28 days before the trial begins
• Have already received neurotropin tablets more than 4 tablets or 3.6 units <4 weeks before the trials begins
• Unable to visit the hospital regularly
• Has been ruled out by investigators
• Brain tumor or metastasis
• Brain injury, stroke and brain hemorrhage symptoms occurred during 6 months after sign the consent
• History of epilepsy, convulsion
• Severe respiratory, cardiovascular, renal, hepatic or hematologic system(except cancer) disease
• Depression and other psychologic conditions which investigators recognized as high risk for the enrollment
• Chronic pain
• Received other medication from other clinical trials within 28 days
• Prepare for pregnancy, pregnant, or lactated women