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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02737735
• Other study ID #: SBao-guo
• Status: Recruiting
• Phase: Phase 1
• First received: March 26, 2016
• Last updated: April 9, 2016
• Start date: March 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Bao-guo Sun, doctor
• Phone: 13316134352
• Email: Sunbaoguo666[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• standard chemotherapy medicine combined with Chinese herbs

• standard chemotherapy medicine

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun-yat Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Questionnaire (EORTC QLQ C30)scores		36months	Yes
Other	RECIST(Response Evaluation Criteria In Solid Tumors)		36months	Yes
Other	KPS scores		36months	Yes
Other	nutritional evaluation scores		36months	Yes
Other	BMS(Bone marrow suppression) scores		36months	Yes
Other	Gastrointestinal reactions scores		36months	Yes
Other	hair loss level scores		36months	Yes
Other	AST value		36months	Yes
Other	ALT value		36months	Yes
Other	creatinine value		36months	Yes
Primary	Overall survival rate		36months	Yes
Primary	progression-free survival rate		36months	Yes