Neurotoxicity
Conditions
Keywords
neurotoxicity, chemotherapy, monosialoganglioside, prevention
Brief summary
The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.
Detailed description
Lung cancer patients received a single-agent albumin-bound paclitaxel chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and blank control group based on segmented block randomized method. After enrollment, patients will complete at least chemotherapy and GM1 injection/blank control. During the 3w per cycle chemotherapy, albumin-bound paclitaxel is conducted in D1 and D8, GM1(40mg+250ml N.S) is injected from D1 to D8. Neurotoxicity evaluation and quality of life assessment will be conducted every cycle and 3m/6m after the chemotherapy.
Interventions
40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.
Sponsors
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
Peking Union Medical College Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Shijitan Hospital, Capital Medical University
Yantai Yuhuangding Hospital
Weifang People's Hospital
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytological and histological confirmation of unresectable locally advanced or metastatic lung cancer diagnosis * No peripheral nervous system diseases exists before * Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity * Enough organ functions reservation and appropriate performance status for chemotherapy * Expected survival period is more than 3 months
Exclusion criteria
* Known or assignment of any of these products to test drugs allergic agent composition * With peripheral neuropathy by any cause before treatment * With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity * Patients with poor general condition to receive chemotherapy * Genetic glucolipid metabolic abnormalities * Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception * Patients cann't avoid neurotrophic drugs * According to the researcher's judgment, the situations inappropriate for patients with ganglioside medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of neurotoxicity | up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| time(days）neurotoxicity arise | up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy |
| Peripheral nerve conduction velocity | up to 4 weeks after the albumin-bound paclitaxel chemotherapy |
Other
| Measure | Time frame |
|---|---|
| time(days) of neurotoxicity adverse events alleviation | up to 180 days after the albumin-bound paclitaxel chemotherapy |
| quality of life | up to 4 weeks after the albumin-bound paclitaxel chemotherapy |
| side effects of monosialoganglioside | up to 4 weeks after the albumin-bound paclitaxel chemotherapy |
Countries
China
Contacts
Primary ContactJian Fang, MD
Backup ContactXiangjuan Ma
Outcome results
None listed