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

This study has been completed.
Information provided by (Responsible Party):
xuling, Shanghai University of Traditional Chinese Medicine Identifier:
First received: July 14, 2011
Last updated: June 23, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: TCM
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: State Administration of Traditional Chinese Medicine of Shanghai

Resource links provided by NLM:

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

Primary Outcome Measures:
  • quality of life(QoL) [ Time Frame: every three weeks ]

Secondary Outcome Measures:
  • two-year disease-free survival rate and disease-free survival [ Time Frame: once every three months ]

Enrollment: 349
Study Start Date: November 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy + TCM group

The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.

Prescriptions formulated into granules origin from Professor Liu Jiaxiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe . Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.

Drug: TCM
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
Other Name: Prescriptions from Professor Liu Jiaxiang
Placebo Comparator: Chemotherapy + placebo group
The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
Drug: placebo
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe,with the same color, smell ,taste weight and package

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01441752

China, Shanghai
Shanghai, Shanghai, China, 200032
Shanghai, Shanghai, China, 200032
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: xuling, State Administration of Traditional Chinese Medicine of Shanghai, Shanghai University of Traditional Chinese Medicine Identifier: NCT01441752     History of Changes
Other Study ID Numbers: LC 001
Study First Received: July 14, 2011
Last Updated: June 23, 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on May 25, 2017