Hao Wei, Liu Sheng, Qin Yuenong, Sun Chenping, Chen Liying, Wu Chunyu, Bao Yijia
Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Trials. 2017 Aug 22;18(1):386. doi: 10.1186/s13063-017-2140-z.
Anthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-associated dose-dependent cardiotoxicity is a limiting factor in clinical use. Extensive efforts have been devoted to identifying strategies to prevent anthracycline-induced cardiotoxicity. However, most cardioprotective agents have shown little effect in clinical trials. Herbal medicines are pure, natural substances that have been used for centuries in many countries, including China. This trial aims to evaluate the cardioprotective effects and safety of Platycodon grandiflorum granules compared to placebo granules in patients with early breast cancer receiving anthracycline-based chemotherapy.
METHOD/DESIGN: This study is a single-center, double-blinded, randomized, placebo-controlled, parallel-group trial. A total of 120 patients will be randomly allocated in a 1:1 ratio to receive either P. grandiflorum granules or placebo granules twice daily for 12 weeks. The primary outcome is heart failure (either clinical or subclinical). The secondary outcomes include all-cause mortality, cardiac death, electrocardiogram (ECG) findings, left ventricular diastolic function, longitudinal systolic strain and velocities measured by tissue Doppler imaging, cardiac biomarkers, such as troponin I (TnI), brain natriuretic peptide (BNP), and creatine kinase isoenzymes (CK-MB). Assessments will be performed at baseline (before randomization) and 3, 6, 9, 12, 16, and 20 weeks after randomization.
This will be the first clinical trial to evaluate the cardioprotective effects and safety of P. grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future.
Chinese Clinical Trial Registry, ChiCTR-IPR-16009256 . Registered on 23 September 2016.
蒽环类药物单独使用或与其他药物联合使用，是辅助和新辅助治疗乳腺癌最有效的化疗药物之一。不幸的是，蒽环类药物相关的剂量依赖性心脏毒性是临床应用中的一个限制因素。人们已付出大量努力来确定预防蒽环类药物所致心脏毒性的策略。然而，大多数心脏保护剂在临床试验中效果甚微。草药是纯净的天然物质，在包括中国在内的许多国家已使用了数百年。本试验旨在评估桔梗颗粒相较于安慰剂颗粒，对接受蒽环类药物化疗的早期乳腺癌患者的心脏保护作用及安全性。
方法/设计：本研究为单中心、双盲、随机、安慰剂对照、平行组试验。总共120名患者将按1:1比例随机分配，每天两次服用桔梗颗粒或安慰剂颗粒，共12周。主要结局是心力衰竭（临床或亚临床）。次要结局包括全因死亡率、心源性死亡、心电图结果、左心室舒张功能、组织多普勒成像测量的纵向收缩应变和速度、心脏生物标志物，如肌钙蛋白I（TnI）、脑钠肽（BNP）和肌酸激酶同工酶（CK-MB）。评估将在基线（随机分组前）以及随机分组后3、6、9、12、16和20周进行。
这将是第一项评估桔梗对接受蒽环类药物化疗的早期乳腺癌患者心脏保护作用及安全性的临床试验。我们进行这项试验也是为了评估未来大规模临床试验的可行性。
中国临床试验注册中心，ChiCTR-IPR-16009256。于2016年9月23日注册。
