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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882621
Recruitment Status : Unknown
Verified May 2016 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : June 1, 2016
Southern Medical University, China
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Monosialoganglioside(GM1) Drug: normal saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by First-line Chemotherapy Contained Cisplatin in Non-small Cell Lung Cancer Patients.
Study Start Date : October 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Monosialoganglioside(GM1)
Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
Drug: Monosialoganglioside(GM1)
80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
Other Name: Monosialotetrahexosylganglioside Sodium Injection

Placebo Comparator: normal saline
placebo 80mg + N.S 250ml,qd,D0-D3
Drug: normal saline
80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Primary Outcome Measures :
  1. incidence rate of neurotoxicity adverse events [ Time Frame: up to 19 weeks after cisplatin chemotherapy ]

Secondary Outcome Measures :
  1. neurotoxicity adverse events alleviation time [ Time Frame: up to 19 weeks after the cisplatin based chemotherapy ]

Other Outcome Measures:
  1. the quality of life of patients [ Time Frame: up to 19 weeks after the cisplatin based chemotherapy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882621

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Contact: Ting Zhou 86-020-87343786
Contact: YuXiang Ma 86-020-87343786

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China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510030
Contact: Ting Zhou    8602087343786   
Sub-Investigator: Yan Huang, Doctor         
Sponsors and Collaborators
Sun Yat-sen University
Southern Medical University, China
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Principal Investigator: LI Zhang, Professor Sun Yat-sen University
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Responsible Party: Li Zhang, Profressor, Sun Yat-sen University Identifier: NCT01882621    
Other Study ID Numbers: GM1-0324
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Li Zhang, Sun Yat-sen University:
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neurotoxicity Syndromes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nervous System Diseases
Chemically-Induced Disorders