Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Peking Union Medical College Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monosialoganglioside | Experimental | patients receive monosialoganglioside. |
|
| control | No Intervention | blank control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monosialoganglioside | Drug | 40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of neurotoxicity | up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy |
| Measure | Description | 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 |
| Measure | Description | 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 | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Fang, MD | Contact | 86-010-88196479 | bcht2_mj@163.com | |
| Xiangjuan Ma | Contact | 86-010-88196459 | juliamarsh@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Fang | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
| Weifang People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| side effects of monosialoganglioside |
| up to 4 weeks after the albumin-bound paclitaxel chemotherapy |