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

• Status: Completed
• Trial end date: 2017-09-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Capecitabine; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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