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

Non-small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01882621
• Other study ID #: GM1-0324
• Status: Recruiting
• Phase: Phase 3
• First received: June 17, 2013
• Last updated: May 28, 2016
• Start date: October 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: Ting Zhou
• Phone: 86-020-87343786
• Email: zhouting[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Neurotoxicity Syndromes
• Non-small Cell Lung Cancer

Intervention

Drug:
• Monosialoganglioside(GM1)
80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
• normal saline
80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	GuangZhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the quality of life of patients		up to 19 weeks after the cisplatin based chemotherapy	Yes
Primary	incidence rate of neurotoxicity adverse events		up to 19 weeks after cisplatin chemotherapy	Yes
Secondary	neurotoxicity adverse events alleviation time		up to 19 weeks after the cisplatin based chemotherapy	Yes