Status:
UNKNOWN
Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Southern Medical University, China
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
Detailed Description
NSCLC patients received a cisplatin-based doublet chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and control group based on segmented block randomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01882621
Start Date
October 1 2013
End Date
August 1 2016
Last Update
June 1 2016
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510030