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

NCT ID: NCT01882621

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-08-31

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 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Monosialoganglioside(GM1)

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

Group Type: ACTIVE_COMPARATOR

Monosialoganglioside(GM1)

Intervention Type: DRUG

80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

normal saline

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Interventions

Monosialoganglioside(GM1)

80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Intervention Type: DRUG

normal saline

80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Intervention Type: DRUG

Other Intervention Names

Monosialotetrahexosylganglioside Sodium Injection

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang

Profressor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LI Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhou

Role: CONTACT

zhouting@sysucc.org.cn

86-020-87343786

YuXiang Ma

Role: CONTACT

mayx@sysucc.org.cn

86-020-87343786

Facility Contacts

Ting Zhou

Role: primary

zhouting@sysucc.org.cn

8602087343786

Other Identifiers

GM1-0324

Identifier Type: -

Identifier Source: org_study_id