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

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ClinicalTrials.gov Identifier: NCT02737735
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sun Bao-guo, 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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: standard chemotherapy medicine combined with Chinese herbs Drug: standard chemotherapy medicine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

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



Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 36months ]
  2. progression-free survival rate [ Time Frame: 36months ]

Other Outcome Measures:
  1. Quality of Life Questionnaire (EORTC QLQ C30)scores [ Time Frame: 36months ]
  2. RECIST(Response Evaluation Criteria In Solid Tumors) [ Time Frame: 36months ]
  3. KPS scores [ Time Frame: 36months ]
  4. nutritional evaluation scores [ Time Frame: 36months ]
  5. BMS(Bone marrow suppression) scores [ Time Frame: 36months ]
  6. Gastrointestinal reactions scores [ Time Frame: 36months ]
  7. hair loss level scores [ Time Frame: 36months ]
  8. AST value [ Time Frame: 36months ]
  9. ALT value [ Time Frame: 36months ]
  10. creatinine value [ Time Frame: 36months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737735


Contacts
Contact: Bao-guo Sun, doctor 13316134352 Sunbaoguo666@126.com
Contact: Xin Zhou, master 13533259616 myeva520@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun-yat Sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Bao-guo Sun, doctor    13316134352    Sunbaoguo666@126.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Sun Bao-guo, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02737735     History of Changes
Other Study ID Numbers: SBao-guo
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases