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 / 中西医结合学报
Journal of Integrative Medicine
;
(12): 175-181, 2014.
Article
in English
| WPRIM
| ID: wpr-308199
ABSTRACT
<p><b>BACKGROUND</b>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.</p><p><b>METHODS AND DESIGN</b>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.</p><p><b>DISCUSSION</b>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.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov. (Identifier NCT01780181).</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Double-Blind Method
/
Prospective Studies
/
Mortality
/
Combined Modality Therapy
/
Carcinoma, Non-Small-Cell Lung
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Disease-Free Survival
/
Drug Therapy
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Lung Neoplasms
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Medicine, Chinese Traditional
Type of study:
Controlled clinical trial
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Diagnostic study
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Observational study
/
Prognostic study
Limits:
Aged
/
Humans
Language:
English
Journal:
Journal of Integrative Medicine
Year:
2014
Type:
Article
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