Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer

The Effect of Monosialotetrahexosylganglioside (GM1) in Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer Patients Who Received Oxaliplatin-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial

The primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Inclusion Criteria:

• Age: 18-75 years old, male or female
• Histologically confirmed diagnosis of colorectal adenocarcinoma with a phase II or III disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mFOLOFX6 or XELOX, without adjuvant radiation indications
• No prior any level of peripheral nerve system disease
• Patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc)
• With the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
• With normal functions of major organs
• No contraindication to chemotherapy
• Life expectancy ≥ 3 months
• Patients have provided a signed Informed Consent Form

Exclusion Criteria:

• Patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy
• Patients who receive palliative chemotherapy
• Patients who need adjuvant or palliative radiotherapy during chemotherapy
• Be allergic to GM1
• Hereditary abnormal metabolism of glucose and lipid
• Doctors believe that patients are not suitable for receiving GM1 treatment
• With confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
• With concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
• Patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures