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The Randomized Controlled Clinical Trial of Kushen Injection

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ClinicalTrials.gov Identifier: NCT02346318
Recruitment Status : Unknown
Verified October 2014 by Beijing Zheng Ju Medical Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 27, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Zheng Ju Medical Technology Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Compound Kushen Injection Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer
Study Start Date : November 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: KS injection arm
Radiation and chemotherapy and compound Kushen Injection
Drug: Compound Kushen Injection
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
Other Name: KS injection

No Intervention: Control arm
Radiation and chemotherapy



Primary Outcome Measures :
  1. The rates of incidence and the degree of adverse reactions caused by redioterapy [ Time Frame: 6 months ]
    radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease


Secondary Outcome Measures :
  1. The completion rate of radiotherapy [ Time Frame: 2 months ]
    Compare two groups of patients with completion of the radiotherapy plans

  2. Clinical Symptoms (MDASI-TCM) [ Time Frame: 6 months ]
    MDASI-TCM

  3. Quality of Life (EORTC QLQ-C30) [ Time Frame: 6 months ]
    EORTC QLQ-C30

  4. ECOG PS (ECOG PS score) [ Time Frame: 6 months ]
    ECOG PS score

  5. Weight [ Time Frame: 6 months ]
    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. Gene molecule detection (EGFR) [ Time Frame: 4 weeks ]
    EGFR

  7. Pulmonary function tests (FEV1,FVC,DLCO) [ Time Frame: 6 months ]
    FEV1,FVC,DLCO

  8. Immune function (Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8) [ Time Frame: 6 months ]
    Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent
  • To be aged from 18 to 75 years old, both gender
  • The lung cancer diagnosis must be proved by pathology
  • According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Lung function FEV1 more than at least 1Land more than 50% A normal value
  • The function of each organ is basically normal :ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN(less than 5*ULN, if with liver metastases), SCr less than 1.5*ULN
  • The expected survival tme must more than 6 months.

Exclusion Criteria:

  • Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks
  • Pregnancy or lactation women
  • Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - Participating or within the last 30 days participated in other clinical trials
  • Hypersensitiveness to any kind of trial regime
  • Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence
  • Estimating the compliance of patients to participate in this clinical trial is insufficient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346318


Contacts
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Contact: Hongsheng Lin, Bachelor 86-10-63200600 bjzhengju@126.com
Contact: Libo Xiao, Bachelor 86-13811646095 13811646095@163.com

Locations
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China, Shandong
Shandong cancer hospital Recruiting
Jinan, Shandong, China
Contact: Shuanghu Yuan, doctor         
Sponsors and Collaborators
Beijing Zheng Ju Medical Technology Co., Ltd.
Investigators
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Principal Investigator: Shuanghu Yuan, postdoctoral Shandong Cancer Hospital

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Responsible Party: Beijing Zheng Ju Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02346318     History of Changes
Other Study ID Numbers: 2014EC085-01
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: October 2014
Keywords provided by Beijing Zheng Ju Medical Technology Co., Ltd.:
Radiotherapy
Adverse Effect
Dermatitis or Eczema
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases