外敷肝敷贴减轻接受放射治疗的转移性癌症患者疲劳的随机临床试验。
External application of liver compresses to reduce fatigue in patients with metastatic cancer undergoing radiation therapy, a randomized clinical trial.
机构信息
Department of Radiation Oncology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.
Division of Oncology and Hematology, Department of Pediatrics, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
出版信息
Radiat Oncol. 2021 Apr 19;16(1):76. doi: 10.1186/s13014-021-01757-x.
BACKGROUND
Liver compresses are frequently used in integrative medicine as supportive therapy during cancer treatment in order to reduce fatigue. We performed a pilot study to test whether the external application of yarrow liver compresses impacts fatigue in patients with metastatic cancer undergoing radiation therapy.
METHODS
A randomized prospective pilot trial was performed including patients with brain metastasis or bone metastasis of solid tumors. Patients underwent either palliative radiation therapy (RT) of the metastatic lesions (control group) over two weeks or the same RT with additional external application of yarrow liver compresses once daily during RT. The primary objective was improvement on the general fatigue subscale of the multidimensional fatigue inventory (MFI-20) at the end of treatment, where a mean difference of two points is considered clinically relevant. Secondary objectives included psychological distress, quality of life and qualitative analysis with self-established visual analogue scales (VAS). Mean differences in general fatigue at the end of treatment compared to baseline were analyzed using the ANCOVA test.
RESULTS
From 09/2017 to 08/2019 a total of 39 patients were randomized. Due to drop outs 24 patients (12 per group) were available for analysis. Patients in the intervention group received a mean number of 10.5 (range, 7-14) applications of yarrow liver compresses. The mean improvement at the end of therapy on the general fatigue subscale of the MFI-20 was 2 points in favor of the intervention group (p = 0.13), and all other MFI-20 subscales showed at least a trend towards improvement in favor of the intervention group. Likewise, psychological distress and VAS data was improved, the latter reaching statistical significance for the symptoms fatigue, tension and lack of drive. Major toxicities were not observed.
CONCLUSIONS
External application of liver compresses appears to reduce fatigue within a clinical relevant range in patients with metastatic cancer undergoing radiation therapy.
TRIAL REGISTRATION
ISRCTN, ICTRP DRKS00012999.
背景
肝脏敷压在癌症治疗中经常被用作辅助疗法，以减轻疲劳。我们进行了一项初步研究，以测试在接受放射治疗的转移性癌症患者中，外部应用蓍草肝脏敷压是否会影响疲劳。
方法
一项随机前瞻性初步试验纳入了患有脑转移或实体瘤骨转移的患者。患者在两周内接受转移性病变的姑息性放射治疗（RT）（对照组），或在接受相同 RT 的同时每天额外进行一次外部应用蓍草肝脏敷压。主要目标是在治疗结束时改善多维疲劳量表（MFI-20）的一般疲劳亚量表，其中平均差异两点被认为具有临床意义。次要目标包括心理困扰、生活质量和自我设定的视觉模拟量表（VAS）的定性分析。使用 ANCOVA 检验分析治疗结束时与基线相比的一般疲劳的平均差异。
结果
从 2017 年 9 月至 2019 年 8 月，共有 39 名患者被随机分配。由于脱落，共有 24 名患者（每组 12 名）可用于分析。干预组患者接受了平均 10.5 次（范围为 7-14 次）蓍草肝脏敷压的治疗。在 MFI-20 的一般疲劳亚量表上，治疗结束时的平均改善为 2 分，有利于干预组（p=0.13），并且所有其他 MFI-20 亚量表都至少显示出有利于干预组的改善趋势。同样，心理困扰和 VAS 数据也有所改善，后者在疲劳、紧张和缺乏动力等症状方面达到统计学意义。未观察到主要毒性。
结论
在接受放射治疗的转移性癌症患者中，外部应用肝脏敷压似乎可以在临床相关范围内减轻疲劳。
试验注册
ISRCTN、ICTRP DRKS00012999。
Zotero 插件