The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
NCT ID: NCT02737735
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
200 participants
INTERVENTIONAL
2016-03-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy combined with compound herbal medicine
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.
standard chemotherapy medicine combined with Chinese herbs
Chemotherapy
The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
standard chemotherapy medicine
Interventions
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standard chemotherapy medicine combined with Chinese herbs
standard chemotherapy medicine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Sun Bao-guo
Principal Investigator
Locations
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The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBao-guo
Identifier Type: -
Identifier Source: org_study_id
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