Trial record 6 of 595 for:
Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients
Verified December 2013 by Sun Yat-sen University
Southern Medical University, China
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
First received: June 17, 2013
Last updated: December 6, 2013
Last verified: December 2013
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
Non-small Cell Lung Cancer
Drug: normal saline
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- incidence rate of neurotoxicity adverse events [ Time Frame: up to 19 weeks after cisplatin chemotherapy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- neurotoxicity adverse events alleviation time [ Time Frame: up to 19 weeks after the cisplatin based chemotherapy ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- the quality of life of patients [ Time Frame: up to 19 weeks after the cisplatin based chemotherapy ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Active Comparator: Monosialoganglioside(GM1)
Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
Other Name: Monosialotetrahexosylganglioside Sodium Injection
Placebo Comparator: normal saline
placebo 80mg + N.S 250ml,qd,D0-D3
Drug: normal saline
80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
Other Name: normal saline
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882621
|Sun Yat-Sen University Cancer Center
|GuangZhou, Guangdong, China, 510030 |
|Contact: Ting Zhou 8602087343786 firstname.lastname@example.org |
|Sub-Investigator: Yan Huang, Doctor |
Sun Yat-sen University
Southern Medical University, China
||LI Zhang, Professor
||Sun Yat-sen University
No publications provided
||Li Zhang, Profressor, Sun Yat-sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 17, 2013
||December 6, 2013
||China: Food and Drug Administration
Keywords provided by Sun Yat-sen University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Nervous System Diseases
Physiological Effects of Drugs