Effect of Astragalus-based Formula: Qingshu-Yiqi-Tang on Modulating Immune Alterations in Lung Cancer Patients (QSYQT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01802021
First received: February 27, 2013
Last updated: February 28, 2013
Last verified: April 2009
  Purpose

The myeloid-derived suppressor cells (MDSCs) can further trigger cytotoxic T cell apoptosis, and may shift the macrophages toward M2 subtype, inhibit the Th1 cell, and initiate other immune suppressive mechanism. The functions of NK cells and regulatory T cells are altered, resulting in a disturbance of anti-tumor immune function. All these can further create an environment with a benefit for malignant cell growth and advancement. Astragalus-based formula may confer its survival advantage in cancer patients through modulating the immune system and reversing the immunosuppressive microenvironment.

The investigators aim to study the role of Qingshu-Yiqi-Tang in reversing the immune alterations in patients with advanced stage, non-small cell lung cancer who receive 1st line doublet chemotherapy of cisplatin plus doxetaxel(or Pemetrexed for adenocarcinoma)and 2nd line target therapy of erlotinib. The investigators can explore the possible mechanism of the Astragalus-based formula: Qingshu-Yiqi-Tang in modulating and reversing immunosuppression in advanced stage, non-small cell lung cancer patients.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Astagalus-based Formula: Qingshu-Yiqi-Tang
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy Study of Chinese Medicine on Modulating Immune Alterations in Advanced Stage, Non-small Cell Lung Cancer Patients Receiving 1st Line Doublet Chemotherapy and 2nd Line Target Therapy

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free interval [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qingshu-Yiqi-Tang+standard therapy

Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy, maximal for 6 months.

1st line doublet chemotherapy: Cisplatin 70 mg/m2+Taxotere 60 mg/m2 D1/Q3W x 6 cycles, and then 2nd line target therapy: Erlotinib 150mg QD.

Drug: Astagalus-based Formula: Qingshu-Yiqi-Tang

Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy.

maximal for 6 months

Other Names:
  • Chuang Song Zong Pharmaceutical Co., Ltd. Taiwan.
  • CHING SHUU YIH CHIH TANG /QING SHU YI QI TANG
No Intervention: 1st line doublet chemotherapy
1st line doublet chemotherapy: Cisplatin 70 mg/m2+Taxotere 60 mg/m2 D1/Q3W x 6 cycles, and then 2nd line target therapy: Erlotinib 150mg QD.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathological diagnosis of primary non-small-cell lung cancer Stage IIIB, IV
  2. Age ≧ 18 years
  3. Written, informed consent
  4. ECOG: 0-1

Exclusion Criteria:

  1. Subjects with inflammatory, infectious or immune disorder, such as TB, AIDS, active pneumonia, DM, SLE, rheumatoid disease.
  2. Subjects with systemic organ disease, such as CHF, ESRD, hepatitis, liver cirrhosis.
  3. Subjects with malignancy other than NSCLC.
  4. Subjects receiving anti-inflammatory or immunosuppressor medications, such as steroid (oral, except for chemotherapy premedication, or inhaled), NSAIDs.
  5. Patients with no willing to sign the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802021

Locations
Taiwan
Center for traditional chinese medicine, Chang Gung Memorial Hospital Recruiting
Gueishan Township, Taoyuan County, Taiwan, 33378
Contact: Tse-Hung Huang, M.D.    +886-3196200 ext 2613    tsehunghuang_1089@yahoo.com.tw   
Principal Investigator: Tse-Hung Huang, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Tse-Hung Huang, M.D. Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01802021     History of Changes
Other Study ID Numbers: 97-1967A3
Study First Received: February 27, 2013
Last Updated: February 28, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
chinese medicine
non-small cell lung cancer
immunosuppression

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

ClinicalTrials.gov processed this record on July 29, 2014