Clinical trial NCT01882621: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Monosialoganglioside(GM1)
neurotoxicity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2013-06-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: incidence rate of neurotoxicity adverse events
timeFrame: up to 19 weeks after cisplatin chemotherapy
Secondary outcomes:
measure: neurotoxicity adverse events alleviation time
timeFrame: up to 19 weeks after the cisplatin based chemotherapy
Other outcomes:
measure: the quality of life of patients
timeFrame: up to 19 weeks after the cisplatin based chemotherapy
Locations:
city: GuangZhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: LI Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: