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

April 9, 2016 updated by: Sun Bao-guo, First Affiliated Hospital, Sun Yat-Sen University
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun-Yat Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: standard chemotherapy medicine combined with Chinese herbs
Active Comparator: Chemotherapy
The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
Drug: standard chemotherapy medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: 36months
36months
progression-free survival rate
Time Frame: 36months
36months

Other Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire (EORTC QLQ C30)scores
Time Frame: 36months
36months
RECIST(Response Evaluation Criteria In Solid Tumors)
Time Frame: 36months
36months
KPS scores
Time Frame: 36months
36months
nutritional evaluation scores
Time Frame: 36months
36months
BMS(Bone marrow suppression) scores
Time Frame: 36months
36months
Gastrointestinal reactions scores
Time Frame: 36months
36months
hair loss level scores
Time Frame: 36months
36months
AST value
Time Frame: 36months
36months
ALT value
Time Frame: 36months
36months
creatinine value
Time Frame: 36months
36months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 26, 2016

First Submitted That Met QC Criteria

April 9, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBao-guo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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