The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
1 other identifier
interventional
200
1 country
1
Brief Summary
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 26, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 14, 2016
March 1, 2016
3.8 years
March 26, 2016
April 9, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Overall survival rate
36months
progression-free survival rate
36months
Other Outcomes (10)
Quality of Life Questionnaire (EORTC QLQ C30)scores
36months
RECIST(Response Evaluation Criteria In Solid Tumors)
36months
KPS scores
36months
- +7 more other outcomes
Study Arms (2)
Chemotherapy combined with compound herbal medicine
EXPERIMENTALStandard 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.
Chemotherapy
ACTIVE COMPARATORThe therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2016
First Posted
April 14, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
April 14, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share