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

Sun Yat-sen University

Status and phase

Unknown

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: standard chemotherapy medicine combined with Chinese herbs

Drug: standard chemotherapy medicine

Study type

Interventional

Funder types

Other

Identifiers

NCT02737735

SBao-guo

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Chemotherapy combined with compound herbal medicine

Experimental group

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.

Treatment:

Drug: standard chemotherapy medicine combined with Chinese herbs

Chemotherapy

Active Comparator group

Description:

The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks

Treatment:

Drug: standard chemotherapy medicine