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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: xuling

Criteria

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.