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The Randomized Controlled Clinical Trial of Kushen Injection

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Compound Kushen Injection

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring Radiotherapy, Adverse Effect, Dermatitis or Eczema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shandong cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KS injection arm

Control arm

Arm Description

Radiation and chemotherapy and compound Kushen Injection

Radiation and chemotherapy

Outcomes

Primary Outcome Measures

The rates of incidence and the degree of adverse reactions caused by redioterapy

radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease

Secondary Outcome Measures

The completion rate of radiotherapy

Compare two groups of patients with completion of the radiotherapy plans

Clinical Symptoms (MDASI-TCM)

MDASI-TCM

Quality of Life (EORTC QLQ-C30)

EORTC QLQ-C30

ECOG PS (ECOG PS score)

ECOG PS score

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"

Gene molecule detection (EGFR)

EGFR

Pulmonary function tests (FEV1,FVC,DLCO)

FEV1,FVC,DLCO

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

Full Information

NCT ID

NCT02346318

First Posted

December 4, 2014

Last Updated

July 20, 2017

Sponsor

Beijing Zheng Ju Medical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02346318

Brief Title

The Randomized Controlled Clinical Trial of Kushen Injection

Official Title

The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Zheng Ju Medical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Radiotherapy, Adverse Effect, Dermatitis or Eczema

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KS injection arm

Arm Type

Experimental

Arm Description

Radiation and chemotherapy and compound Kushen Injection

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Radiation and chemotherapy

Intervention Type

Drug

Intervention Name(s)

Compound Kushen Injection

Other Intervention Name(s)

KS injection

Intervention Description

Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.

Primary Outcome Measure Information:

Title

The rates of incidence and the degree of adverse reactions caused by redioterapy

Description

radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease

Time Frame

6 months

Secondary Outcome Measure Information:

Title

The completion rate of radiotherapy

Description

Compare two groups of patients with completion of the radiotherapy plans

Time Frame

2 months

Title

Clinical Symptoms (MDASI-TCM)

Description

MDASI-TCM

Time Frame

6 months

Title

Quality of Life (EORTC QLQ-C30)

Description

EORTC QLQ-C30

Time Frame

6 months

Title

ECOG PS (ECOG PS score)

Description

ECOG PS score

Time Frame

6 months

Title

Weight

Description

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

Title

Gene molecule detection (EGFR)

Description

EGFR

Time Frame

4 weeks

Title

Pulmonary function tests (FEV1,FVC,DLCO)

Description

FEV1,FVC,DLCO

Time Frame

6 months

Title

Immune function (Observation indexes including NK、T lymphocyte subpopulation（CD3、CD4、CD8）、CD4/CD8)

Description

Observation indexes including NK、T lymphocyte subpopulation（CD3、CD4、CD8）、CD4/CD8

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongsheng Lin, Bachelor

Phone

86-10-63200600

bjzhengju@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Libo Xiao, Bachelor

Phone

86-13811646095

13811646095@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuanghu Yuan, postdoctoral

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shandong cancer hospital

City

Jinan

State/Province

Shandong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuanghu Yuan, doctor

12. IPD Sharing Statement

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The Randomized Controlled Clinical Trial of Kushen Injection

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