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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Li Zhang, Sun Yat-sen University
Southern Medical University, China
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University Identifier:
First received: June 17, 2013
Last updated: May 28, 2016
Last verified: May 2016
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Li Zhang, Sun Yat-sen University:

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

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

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

Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01882621

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

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
Principal Investigator: LI Zhang, Professor Sun Yat-sen University
  More Information

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University Identifier: NCT01882621     History of Changes
Other Study ID Numbers: GM1-0324
Study First Received: June 17, 2013
Last Updated: May 28, 2016

Keywords provided by Li Zhang, Sun Yat-sen University:

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nervous System Diseases
Chemically-Induced Disorders
Antineoplastic Agents processed this record on September 21, 2017