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首页> 外文期刊>BMC Complementary and Alternative Medicine >Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients
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Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients

机译：联合或不联合中药化疗对非小细胞肺癌患者术后生活质量的多中心随机双盲对照临床研究

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Background Traditional Chinese medicine (TCM) is a widely applied complementary therapy for cancer patients. It can reduce the chemical drugs induced toxic effects to improve the quality of life (QOL). This study applies the highest quality of clinical trial methodology to examine the role of TCM in improving QOL of postoperative non-small-cell lung cancer patients. Methods and design This study is a multi-center, randomized, placebo-controlled, double-blind trial. Four hundred eighty patients will be recruited into seven different research centers in China. These patients that meet the inclusion criteria will be randomized into either a treatment group or a placebo group. Each group will receive treatments of 3-weekly chemotherapy with TCM or placebo for four cycles. The primary outcome will involve the evaluation of QOL and the secondary outcome assessments will include two-year disease-free survival rate and disease-free survival. Other efficacy assessments are changes of TCM symptoms and toxicity. Side effects and safety profile of the therapy would be evaluated at the same time. The investigators expect that TCM therapy combined with chemotherapy is superior to chemotherapy solely in terms of QOL improvement and disease-free survival extension. "Intention-to-treat" analysis will include all randomized participants. Discussion The results from the clinical trial will provide evidence for the effectiveness of chemotherapy combined with or without TCM in QOL of postoperative NSCLC patients. Trial registration Clinical Trials.gov (Identifier: NCT01441752).
机译：背景技术中药（TCM）是癌症患者广泛应用的辅助疗法。它可以减少化学药物引起的毒性作用，从而改善生活质量（QOL）。这项研究采用最高质量的临床试验方法来检验中药在改善术后非小细胞肺癌患者生活质量中的作用。方法和设计本研究是一项多中心，随机，安慰剂对照，双盲试验。 480名患者将被招募到中国的七个不同研究中心。这些符合纳入标准的患者将被随机分为治疗组或安慰剂组。每组将接受为期3周的中药或安慰剂化疗，为期4个周期。主要结局将涉及QOL评估，次要结局评估将包括两年无病生存率和无病生存期。其他功效评估是中医症状和毒性变化。该疗法的副作用和安全性将同时评估。研究人员期望，仅在QOL改善和无病生存期延长方面，中医联合化疗优于化疗。 “意向治疗”分析将包括所有随机参与者。讨论该临床试验的结果将为化疗加或不加中药对术后NSCLC患者QOL的有效性提供证据。试验注册Clinical Trials.gov（标识符：NCT01441752）。

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