The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation

Phase 1

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: standard chemotherapy medicine combined with Chinese herbs; Drug: standard chemotherapy medicine

• Registration Number: NCT02737735
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-26
• Study First Submitted QC: 2016-04-09
• Last Update Submitted: 2016-04-09
• Study First Posted: 2016-04-14
• Last Update Posted: 2016-04-14
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy combined with compound herbal medicine	standard chemotherapy medicine combined with Chinese herbs	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.
Chemotherapy	standard chemotherapy medicine	The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks

Primary Outcome Measures

Name	Time	Method
progression-free survival rate	36months
Overall survival rate	36months

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun-yat Sen University; 🇨🇳 GuangZhou, Guangdong, China