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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
- Source :
- Journal of integrative medicine. 12(3)
- Publication Year :
- 2014
-
Abstract
- BACKGROUND Traditional Chinese medicine (TCM) is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer (NSCLC) are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM. Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles. Progression-free survival (PFS) is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life (EORTC QLQ-LC43, and TCM syndrome score). Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC. TRIAL REGISTRATION ClinicalTrials.gov. (Identifier: NCT01780181).
- Subjects :
- Oncology
medicine.medical_specialty
Lung Neoplasms
Traditional Chinese medicine
Disease-Free Survival
law.invention
Randomized controlled trial
Quality of life
Double-Blind Method
law
Internal medicine
Carcinoma, Non-Small-Cell Lung
Clinical endpoint
Medicine
Humans
Progression-free survival
Prospective Studies
Medicine, Chinese Traditional
Prospective cohort study
Lung cancer
Aged
Traditional medicine
business.industry
Cancer
General Medicine
medicine.disease
Combined Modality Therapy
humanities
business
Subjects
Details
- ISSN :
- 20954964
- Volume :
- 12
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Journal of integrative medicine
- Accession number :
- edsair.doi.dedup.....3028de354259d91d75a6f974a37ae82b