Clinical trial · Observational
Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer
NCT01780181CI-TRIAL-00024325completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| TCM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TCM plus chemotherapy
- description
- TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang, four packages,twice a day, three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
- interventionNames
- Drug: TCM
- Drug: Chemotherapy
- label
- Placebo plus chemotherapy
- description
- TCM Placebo: oral granules,YangYinFang orYiQiFang or YiQiYangYinFang, 10% of the original dose,four packages,twice a day ,three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ; 2. Ages Eligible for Study: ≥65 years old; 3. Physical status score (ECOG PS) ≤ 2 scores; 4. Estimated life expectancy of at least 12 weeks; 5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥9g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin≤1.5ULN,alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range(1.2DLN-1.2ULN),creatinine≤1.5ULN; 6. Informed consent from the patient. Exclusion Criteria: 1. Patient with other malignant tumor except NSCLC 5 years previous to study entry. 2. Patients who have received single-agent chemotherapy treatment; 3. Estimated life expectancy less than 12 weeks; 4. Serious problem of heart, liver or kidney with severe dysfunction; 5. Pregnant or child breast feeding women; 6. Mental or cognitive disorders; 7. Participating in other drug trials; 8. Who are allergic to the study drug.
References
Publications (1)
- DERIVEDZhou ZY, Xu L, Li HG, Tian JH, Jiao LJ, You SF, Han ZF, Jiang Y, Guo HR, Liu H. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: protocol for a randomized double-blind controlled trial. J Integr Med. 2014 May;12(3):175-81. doi: 10.1016/S2095-4964(14)60028-5. PMID 24861837