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Journal of Integrative Medicine ›› 2014, Vol. 12 ›› Issue (3): 175-181.doi: 10.1016/S2095-4964(14)60028-5

• Study Protocol • Previous Articles     Next Articles

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

Zhi-yi Zhoua, Ling Xua, He-gen Lia, Jian-hui Tiana, Li-jing Jiaoa, Sheng-fu Youa, Zhi-fen Hanb, Yi Jianga, Hui-ru Guoa, Hui Liub   

  1. a Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    b Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
  • Received:2014-04-09 Accepted:2014-04-15 Online:2014-05-10 Published:2014-05-15

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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).

Key words: Non-small-cell lung carcinomas, Chemotherapy, Traditional medicine, Chinese, progression-free survival, Randomized controlled trials, Study protocol

Figure 1

Flow diagram of the study ^ PFS: progression-free survival; OS: overall survival; ORR: objective response rate; TTP: time-to-progression; QOL: quality of life."

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