Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients
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.
1 other identifier
interventional
300
1 country
1
Brief Summary
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Oct 2013
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 1, 2016
May 1, 2016
2.8 years
June 17, 2013
May 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence rate of neurotoxicity adverse events
up to 19 weeks after cisplatin chemotherapy
Secondary Outcomes (1)
neurotoxicity adverse events alleviation time
up to 19 weeks after the cisplatin based chemotherapy
Other Outcomes (1)
the quality of life of patients
up to 19 weeks after the cisplatin based chemotherapy
Study Arms (2)
Monosialoganglioside(GM1)
ACTIVE COMPARATORMonosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
normal saline
PLACEBO COMPARATORplacebo 80mg + N.S 250ml,qd,D0-D3
Interventions
80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Southern Medical University, Chinacollaborator
Study Sites (1)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LI Zhang, Professor
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profressor
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 20, 2013
Study Start
October 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 1, 2016
Record last verified: 2016-05