Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin

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

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Southern Medical University, China
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Cytological and histological confirmation of non-small cell lung cancer (NSCLC) diagnosis, single sputum cytology diagnosis is not accepted

• Expected survival period is more than 3 months

• Enough blood function reservation: absolute neutrophil count (ANC) 2 x 10E9/L or higher;platelet count 100 x 109 /L or higher;hemoglobin 9 g/dL or higher.

• Enough liver function reservation:the total bilirubin less than upper limit of normal;AST and ALT acuities were less than 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal (ULN) or less.

• Clinical doctors identify patients suitable for standard doses of ganglioside drug therapy, and expected time of medication is at least six weeks

• Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs chemical treatment.

• No more than 1 degree of the peripheral nervous system diseases exists before enrollment, also no other symptom or disease could affect the adverse reactions of neurotoxicity pathological.

• Can't accept other adverse reactions may prevent neurotoxicity treatment or care after enrollment.

• Sign the informed consent form.

Exclusion Criteria:

• Patients with poor general condition, PS score more than 2 points

• Women in pregnancy or lactation

• Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception

• With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity

• Known or assignment of any of these products to test drugs allergic agent composition

• Doctors think inappropriate for patients with ganglioside medication or estimated time of less than 6 weeks

• Active infection (determined by the researcher)

• According to the researcher's judgment, there is serious disease to endanger the safety of patients, or may prevent the patients from completing the study

• Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia