The Randomized Controlled Clinical Trial of Kushen Injection

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongsheng Lin, Bachelor
  • Phone Number: 86-10-63200600
  • Email: bjzhengju@126.com

Study Contact Backup

Study Locations

    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Shuanghu Yuan, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KS injection arm
Radiation and chemotherapy and compound Kushen Injection
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
Other Names:
  • KS injection
No Intervention: Control arm
Radiation and chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The completion rate of radiotherapy
Time Frame: 2 months
Compare two groups of patients with completion of the radiotherapy plans
2 months
Clinical Symptoms (MDASI-TCM)
Time Frame: 6 months
MDASI-TCM
6 months
Quality of Life (EORTC QLQ-C30)
Time Frame: 6 months
EORTC QLQ-C30
6 months
ECOG PS (ECOG PS score)
Time Frame: 6 months
ECOG PS score
6 months
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 months
Gene molecule detection (EGFR)
Time Frame: 4 weeks
EGFR
4 weeks
Pulmonary function tests (FEV1,FVC,DLCO)
Time Frame: 6 months
FEV1,FVC,DLCO
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shuanghu Yuan, postdoctoral, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

October 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on Compound Kushen Injection

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