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The randomized controlled multicenter clinical study of compound Kushen Injection to reduce the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials,The main purpose is to evaluate the effect of compound Kushen Injection in preventing and reducing the radiotherapy related adverse reactions. The participants of the clinical trials are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group of participants is given compound Kushen Injection with chemoradiotherapy, while another group is only given chemoradiotherapy. The period of trials is 18 months.
Patients with lung cancer who need thoracic radiotherapy will be enrolled in the trial, then seprated randomly in two group,the KS injection group treated with chemoradiotherapy plus KS injection; the contral group treated with chemoradiotherapy only. After 6 months observation, The rates of incidence and the degree of adverse reactions caused by redioterapy; the completion rate of radiotherapy; clinical Symptoms; Qof and pulmonary function tests etc. will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KS injection arm | Experimental | Radiation and chemotherapy and compound Kushen Injection |
|
| Control arm | No Intervention | Radiation and chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Kushen Injection | Drug | Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rates of incidence and the degree of adverse reactions caused by redioterapy | radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The completion rate of radiotherapy | Compare two groups of patients with completion of the radiotherapy plans | 2 months |
| Clinical Symptoms (MDASI-TCM) | MDASI-TCM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongsheng Lin, Bachelor | Contact | 86-10-63200600 | bjzhengju@126.com | |
| Libo Xiao, Bachelor | Contact | 86-13811646095 | 13811646095@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuanghu Yuan, postdoctoral | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong cancer hospital | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 6 months |
| Quality of Life (EORTC QLQ-C30) | EORTC QLQ-C30 | 6 months |
| ECOG PS (ECOG PS score) | ECOG PS score | 6 months |
| Weight | After the treatment,Healing after weight 1 kg to "add",Reduce 1 kg to "fall",Less than 1 kg of change as a "stable" | 6 months |
| Gene molecule detection (EGFR) | EGFR | 4 weeks |
| Pulmonary function tests (FEV1,FVC,DLCO) | FEV1,FVC,DLCO | 6 months |
| Immune function (Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8) | Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8 | 6 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |