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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Monosialoganglioside(GM1); Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01882621

GM1-0324

Details and patient eligibility

About

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

Full 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 randomized method. After enrollment, patients should complete four or six chemotherapy and GM1/placebo injection. During the 3w per cycle chemotherapy, cisplatin injection is conducted in D1/D1-3, GM1/placebo (80mg+250ml N.S) is injected from D0 to D3. Neurotoxicity evaluation and quality of life (FACT-NTX and EROTC scale) assessment will be conducted every cycle and 3w/11w/19w after the chemotherapy.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

Monosialoganglioside(GM1)

Active Comparator group

Description:

Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3

Treatment:

Drug: Monosialoganglioside(GM1)

normal saline

Placebo Comparator group

Description:

placebo 80mg + N.S 250ml,qd,D0-D3

Treatment:

Drug: normal saline