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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Monosialoganglioside(GM1)

normal saline

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Monosialoganglioside(GM1), neurotoxicity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Monosialoganglioside(GM1)

normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence rate of neurotoxicity adverse events

Secondary Outcome Measures

neurotoxicity adverse events alleviation time

Full Information

NCT ID

NCT01882621

First Posted

June 17, 2013

Last Updated

May 28, 2016

Sponsor

Sun Yat-sen University

Collaborators

Southern Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT01882621

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Southern Medical University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

NSCLC, Monosialoganglioside(GM1), neurotoxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Monosialoganglioside(GM1)

Arm Type

Active Comparator

Arm Description

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

Arm Title

normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Monosialoganglioside(GM1)

Other Intervention Name(s)

Monosialotetrahexosylganglioside Sodium Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

incidence rate of neurotoxicity adverse events

Time Frame

up to 19 weeks after cisplatin chemotherapy

Secondary Outcome Measure Information:

Title

neurotoxicity adverse events alleviation time

Time Frame

up to 19 weeks after the cisplatin based chemotherapy

Other Pre-specified Outcome Measures:

Title

the quality of life of patients

Time Frame

up to 19 weeks after the cisplatin based chemotherapy

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Zhou

Phone

86-020-87343786

zhouting@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

YuXiang Ma

Phone

86-020-87343786

mayx@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LI Zhang, Professor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

GuangZhou

State/Province

Guangdong

ZIP/Postal Code

510030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ting Zhou

Phone

8602087343786

zhouting@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Yan Huang, Doctor

12. IPD Sharing Statement

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

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