Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Shanghai University of Traditional Chinese Medicine
Information provided by (Responsible Party):
xuling, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
First received: July 14, 2011
Last updated: July 5, 2012
Last verified: June 2012

The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone.

Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: State Administration of Traditional Chinese Medicine of Shanghai

Resource links provided by NLM:

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Estimated Enrollment: 600
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
TCM combined with CT group

Detailed Description:

At present the high rate of recurrence and metastasis of postoperative non-small cell lung cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung cancer. More than 35% of postoperative lung cancer patients with stage I died in 5 years due to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%, 17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy after resection, so regimen consist of platinum-based two chemical medicines are commended as the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival and improve QOL, but high-level evidences are needed.

The investigators perform a randomized, double-blind study in NSCLC patients after complete resection with stage I-III. Patients are randomized over observational group (TCM granules plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will observe 4 treatment periods, after that the observational group will be treated for another 4 months with integrated TCM combined with western medicine treatment (oral TCM medicines plus TCM intravenous injections), and there is no intervene measures in control group. Regular follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales); Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA, CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with Western medicine treatment has a better efficacy on improving QOL of patients, prolonging disease-free survival time than that of chemotherapy treatment. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

NSCLC patients received complete resection with clear pathological diagnosis and stage I ~ Ⅲ; TCM syndromes are deficiency of Yin, deficiency of Qi, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney.


Inclusion Criteria:

  1. Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients;
  2. Age > 18 years old;
  3. TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney;
  4. Physical status score (ECOG PS) ≤ 2 scores;
  5. Stage Ib ~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size > 2cm of stage Ia;
  6. Blood routine: N > 1.5×109/L、PLT > 100×109/L, normal liver function and kidney function;
  7. Voluntarily involved to clinical study and sign informed consent.

Exclusion Criteria:

  1. Suffering from other primary malignant tumor in 5 years;
  2. Incomplete resection or uncertain to take resection;
  3. Serious disease of heart, liver, kidney with severe dysfunction;
  4. Pregnancy or breast-feeding women;
  5. Mental or cognitive disorders which would influence judgment of QOL in this study;
  6. During or had adjuvant chemotherapy;
  7. Being participating other drug trials;
  8. Allergy to the drug in our study.
  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: NCT01441752

Contact: xu ling 64385700-1313 xulq67@gmail.com

China, Shanghai
ShanghaiUTCM Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Xu Ling    64385700-1313    xulq67@gmail.com   
Xuling Recruiting
Shanghai, Shanghai, China, 200032
Contact: xu ling    64385700-1313    xulq67@gmail.com   
Sponsors and Collaborators
Principal Investigator: xu ling Shanghai University of Traditional Chinese Medicine
Principal Investigator: xu ling, doctor Shanghai University of Traditional Chinese Medicine
  More Information

No publications provided by Shanghai University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: xuling, State Administration of Traditional Chinese Medicine of Shanghai, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01441752     History of Changes
Other Study ID Numbers: LC 001
Study First Received: July 14, 2011
Last Updated: July 5, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

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

ClinicalTrials.gov processed this record on October 23, 2014