Back to resultsThe Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
standard chemotherapy medicine combined with Chinese herbs
standard chemotherapy medicine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion Criteria:
- Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages
- Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
- White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
- ALT, AST, normal or less than 2 times, bilirubin is normal
- Serum level in the normal range;Thr ecg is normal
- Expected survival time≥ 3 months or more;
- Agreed to the treatment combined traditional Chinese medicine with western medicine
Exclusion Criteria:
- Engaged in other clinical subjects
- Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
- Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
- Severe damage of heart, liver and kidney (cardiac function grade 3 ~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
- Mental illness, Refused to partner; Cannot obtain informed consent
Sites / Locations
- The First Affiliated Hospital of Sun-yat Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemotherapy combined with compound herbal medicine
Chemotherapy
Arm Description
Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis.
The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
Outcomes
Primary Outcome Measures
Overall survival rate
progression-free survival rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02737735
First Posted
March 26, 2016
Last Updated
April 9, 2016
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02737735
Brief Title
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy combined with compound herbal medicine
Arm Type
Experimental
Arm Description
Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
Intervention Type
Drug
Intervention Name(s)
standard chemotherapy medicine combined with Chinese herbs
Intervention Type
Drug
Intervention Name(s)
standard chemotherapy medicine
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
36months
Title
progression-free survival rate
Time Frame
36months
Other Pre-specified Outcome Measures:
Title
Quality of Life Questionnaire (EORTC QLQ C30)scores
Time Frame
36months
Title
RECIST(Response Evaluation Criteria In Solid Tumors)
Time Frame
36months
Title
KPS scores
Time Frame
36months
Title
nutritional evaluation scores
Time Frame
36months
Title
BMS(Bone marrow suppression) scores
Time Frame
36months
Title
Gastrointestinal reactions scores
Time Frame
36months
Title
hair loss level scores
Time Frame
36months
Title
AST value
Time Frame
36months
Title
ALT value
Time Frame
36months
Title
creatinine value
Time Frame
36months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages
Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
ALT, AST, normal or less than 2 times, bilirubin is normal
Serum level in the normal range;Thr ecg is normal
Expected survival time≥ 3 months or more;
Agreed to the treatment combined traditional Chinese medicine with western medicine
Exclusion Criteria:
Engaged in other clinical subjects
Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
Severe damage of heart, liver and kidney (cardiac function grade 3 ~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
Mental illness, Refused to partner; Cannot obtain informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bao-guo Sun, doctor
Phone
13316134352
Email
Sunbaoguo666@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhou, master
Phone
13533259616
Email
myeva520@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Sun-yat Sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bao-guo Sun, doctor
Phone
13316134352
Email
Sunbaoguo666@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
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