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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
Shandong cancer hospital
Jinan, Shandong, China
RECRUITINGThe rates of incidence and the degree of adverse reactions caused by redioterapy
radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease
Time frame: 6 months
The completion rate of radiotherapy
Compare two groups of patients with completion of the radiotherapy plans
Time frame: 2 months
Clinical Symptoms (MDASI-TCM)
MDASI-TCM
Time frame: 6 months
Quality of Life (EORTC QLQ-C30)
EORTC QLQ-C30
Time frame: 6 months
ECOG PS (ECOG PS score)
ECOG PS score
Time frame: 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"
Time frame: 6 months
Gene molecule detection (EGFR)
EGFR
Time frame: 4 weeks
Pulmonary function tests (FEV1,FVC,DLCO)
FEV1,FVC,DLCO
Time frame: 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
Time frame: 6 months
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