The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial.
The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-020-04749-6
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发表时间：
2020-10-12
期刊：
影响因子：
2.5
通讯作者：
Xue X
中科院分区：
文献类型：
--
作者：
Ji Y;Li S;Zhang X;Liu Y;Lu Q;Li Q;Chen W;Sheng J;Jiang K;Liang H;Sha S;Li M;Chen Z;Zheng P;Wang M;Feng Y;Wang L;Wu H;Liu H;Huang Y;Yin Z;Xue X
中药治疗乳腺癌的历史悠久，但缺乏系统的证据来支持其临床益处。本研究探讨艾灸加煎剂对早期乳腺癌化疗所致骨髓抑制（CIM）的预防和治疗作用。这是一项中药汤剂而非艾灸的单盲随机对照临床试验。根据年龄（40岁以下、40岁以上、50岁以上、60岁以上）、化疗方案（蒽环类药物、紫杉烷类药物、蒽环类药物+紫杉烷类药物等）、化疗策略（辅助、新辅助）等分层因素，将患者平均分为无煎艾灸组（control）、煎艾灸组（MD）、安慰剂+艾灸组（MP）。中药汤剂为文参升白汤。预计样本量为462例（每组154例）。所有参与者预计将接受化疗和重组人粒细胞集落刺激因子（rhG-CSF）治疗。主要结局包括缓解白细胞减少和/或中性粒细胞减少的患者比例，骨髓抑制相关的严重不良事件，包括3-4级白细胞减少和/或中性粒细胞减少，以及发热性中性粒细胞减少，以及rhG-CSF的剂量。次要结局包括化疗依从性、分层分析、不良反应、生活质量（EORTC乳腺癌特异性生活质量问卷包括EORTC QLQ-C30 （V3.0）和QLQ-BR23）、中医体质、3年无病生存期和总生存期。基线信息包括年龄、手术方式、化疗方案和策略、病理分期和分子亚型。本研究将是首个评价艾灸联合中药汤剂治疗早期乳腺癌患者CIM疗效的随机对照试验，旨在规范中药汤剂和艾灸方法，为其临床获益提供依据。chictr.org.cn chictr -印度卢比16009557。注册于2016年10月23日。
Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients. This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3–4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded. This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit. chictr.org.cn ChiCTR-INR-16009557. Registered on 23 October 2016.
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影响因子：
158.5
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