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| Name | Class |
|---|---|
| Hubei Mon Yan Pharmaceutical Co., Ltd | UNKNOWN |
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The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with non-small-cell lung cancer.
The Clinical trail is a multicenter, prospective, randomized controlled study. The planned sample size is 240 subjects. These subjects will be randomized (1:1) to treatment group (Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid) or control group ( Platinum-based two medicine (carboplatin / cisplatin) plus blank control). The study population includes the patients with non-small-cell lung cancer .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid. |
|
| Control group | Experimental | Blank control and Platinum-based two medicine (carboplatin / cisplatin) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sheng Bai oral liquid | Drug | Drug: Sheng Bai oral liquid 40 mL, oral use, thrice daily after screening on the same day in the second course of the chemotherapy. Subjects will be treated for 2 courses |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and degree of neutropenia after chemotherapy | Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia | six weeks |
| The recovery time of neutropenia | Comparison of the recovery time between two groups of Polymorphonuclear neutropenia | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy | Comparison of the incidence of fever with neutropenia in two chemotherapy cycles between two groups. | six weeks |
| The incidence of Peripheral blood thrombocytopenia disease |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic Testing | The changes of body index before and after treatment were compared between two groups of subjects. | six weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongsheng Lin, Professor | Contact | 010-88001192 | drlinhongsheng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongsheng Lin, Professor | CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Label | URL |
|---|---|
| Standards for the diagnosis and treatment of primary lung cancer (2015 version) in China | View source |
| NCCN Guidelines® : China Editions | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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These subjects will be randomized (1:1) to treatment group or control group.
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| Platinum-based two medicine (carboplatin / cisplatin) . | Drug | Using Platinum-based two medicine (carboplatin / cisplatin) |
|
Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03. |
| six weeks |
| The duration of Peripheral blood thrombocytopenia disease | Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03. | six weeks |
| THE incidence and duration of hemoglobin reduction in peripheral blood | Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03. | six weeks |
| THE duration of hemoglobin reduction in peripheral blood | Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03. | six weeks |
| THE incidence and duration of peripheral blood leukocyte reduction | Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03. | six weeks |
| The duration of peripheral blood leukocyte reduction | Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03. | six weeks |
| The time when the neutrophils were reduced to the lowest point after chemotherapy | Comparison of the time when the neutrophils were reduced to the lowest point after chemotherapy in two chemotherapy cycles between the two groups. | six weeks |
| Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy | Comparison of neutrophil values between two groups when neutrophils were reduced to the lowest point after chemotherapy | six weeks |
| MDASI-TCM | Comparison of the TCM syndrome score changes between two groups before and after treatment.(if you want see the scale information ,you can reference to the link:https://www.mdanderson.org/content/dam/mdanderson/documents/Departments-and-Divisions/Symptom-Research/MDASI-TCM\_SAMPLE.pdf) | six weeks |
| Cancer-related fatigue | Comparison of the degree of fatigue changes between two groups before and after treatment. | six weeks |
| rhG-CSF dosage | Comparison of the rhG-CSF dosage between two groups before and after treatment. | six weeks |
| Immune Index (optional) | Observed indicators include IL-2, INF, NK cells, CD4 +, CD8 +, divided according to the results increased(After treatment than before treatment to improve ≥ 10%, or returned to normal by the abnormalities), decreased(After treatment than before treatment decreased ≥ 10%, or from normal to abnormal changes), stable(After treatment than before treatment, decreased less than 10% or maintained within the normal range). | six weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |