Effects of infrared laser moxibustion on cancer-related fatigue in breast cancer survivors Study protocol for a randomized controlled trial
Effects of infrared laser moxibustion on cancer-related fatigue in breast cancer survivors Study protocol for a randomized controlled trial
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红外激光艾灸对乳腺癌幸存者癌症相关性疲劳的影响随机对照试验研究方案
DOI：
10.1097/md.0000000000016882
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发表时间：
2019-08-01
期刊：
影响因子：
1.6
通讯作者：
Shen, Xueyong
中科院分区：
文献类型：
--
作者：
Mao, Huijuan;Mao, Jun J.;Shen, Xueyong
背景资料：癌症相关性疲劳（CRF）是乳腺癌幸存者（BCS）经历的与癌症治疗相关的最常见和最令人痛苦的症状。我们以前发现激光灸可能对慢性肾衰竭有效。本研究的主要目的是确定10.6mm红外激光灸治疗慢性肾功能衰竭的特异性疗效。第二个目的是评估红外激光灸对BCS并存症状的影响。研究方法：我们将在患有中度至重度疲劳的BCS中进行一项随机、假对照、三臂试验，即红外激光灸（ILM）与假ILM（SILM）和等待名单对照（WLC）。两个干预组将接受真实的或假的红外激光灸四个穴位（即，ST 36 [双侧]、CV 4和CV 6），每次20分钟，持续6周（每周两次）。主要终点是通过中文版简明疲劳量表（BFI-C）测量的疲劳评分从基线至第6周的变化。我们的次要目的是比较合并症的严重程度（e。例如，在一个实施例中，抑郁、失眠、疼痛）。讨论内容：我们的试验结果将为红外激光灸治疗慢性肾功能衰竭（一种非常常见且具有挑战性的症状）的疗效提供证据。
Background: Cancer-related fatigue (CRF) is the most common and distressing symptom associated with cancer treatment that breast cancer survivors (BCS) experience. We previously found that laser moxibustion may be efficacious for CRF. The primary aim of this study is to determine the specific efficacy of 10.6mm infrared laser moxibustion on CRF. The secondary aim is to evaluate the effect of infrared laser moxibustion on co-existing symptoms that BCS experience. Methods: We will conduct a randomized, sham-controlled, three-arm trial of infrared laser moxibustion (ILM) against sham ILM (SILM) and waitlist control (WLC) among BCS with moderate to severe fatigue. The two intervention groups will receive either real or sham infrared laser moxibustion on four acupoints (i.e., ST36 [bilateral], CV4, and CV6) for 20 minutes each session for 6 weeks (twice per week). The primary endpoint is the change in fatigue score from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aim is to compare the severity of co-morbidities (e. g., depression, insomnia, and pain) among the 3 groups. Discussion: The results of our trial will establish evidence for the efficacy of infrared laser moxibustion for CRF, a very common and challenging symptom.