CClinicalTrials.gg
Status unknownNCT01882621Updated Jun 1, 2016

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

A Phase 3 interventional study of Monosialoganglioside(GM1) and normal saline in Non-small Cell Lung Cancer, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • NSCLC
  • Monosialoganglioside(GM1)
  • neurotoxicity
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Monosialoganglioside(GM1)

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

    Drug: Monosialoganglioside(GM1)

  • Placebo comparator
    normal saline

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

    Drug: normal saline

Interventions

  • DrugMonosialoganglioside(GM1)

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

    Also known as: Monosialotetrahexosylganglioside Sodium Injection

  • Drugnormal saline

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

06

What researchers measure

Primary outcomes

  1. incidence rate of neurotoxicity adverse events

    Time frame: up to 19 weeks after cisplatin chemotherapy

Secondary outcomes

  1. neurotoxicity adverse events alleviation time

    Time frame: up to 19 weeks after the cisplatin based chemotherapy

Other outcomes

  1. the quality of life of patients

    Time frame: up to 19 weeks after the cisplatin based chemotherapy

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-Sen University Cancer Center
    GuangZhou, Guangdong 510030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01882621
Lead sponsor
Sun Yat-sen University
Collaborators
Southern Medical University, China
Responsible party
Li Zhang (Profressor, Sun Yat-sen University) — Principal investigator
First posted
Jun 20, 2013
Start date
Oct 2013
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Jun 1, 2016

Study contacts

Ting Zhou
Contact
zhouting@sysucc.org.cn
86-020-87343786
YuXiang Ma
Contact
mayx@sysucc.org.cn
86-020-87343786
LI Zhang, Professor
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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