含辅酶Q10和L-肉碱的氨基酸果冻对接受化疗的乳腺癌患者控制疲劳的疗效和安全性：一项多机构、随机、探索性试验（JORTC-CAM01）
Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).
作者信息
Iwase Satoru, Kawaguchi Takashi, Yotsumoto Daisuke, Doi Takako, Miyara Kyuichiro, Odagiri Hiroki, Kitamura Kaoru, Ariyoshi Keisuke, Miyaji Tempei, Ishiki Hiroto, Inoue Kenichi, Tsutsumi Chizuko, Sagara Yoshiaki, Yamaguchi Takuhiro
机构信息
Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.
Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji, Tokyo, 192-0392, Japan.
出版信息
Support Care Cancer. 2016 Feb;24(2):637-646. doi: 10.1007/s00520-015-2824-4. Epub 2015 Jun 24.
PURPOSE
Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients. This randomized trial investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
METHODS
Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
RESULTS
Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Median patient age was 50 years. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
CONCLUSION
IP may control moderate-severe CRF in breast cancer patients.
TRIAL REGISTRATION
The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.
目的
癌症相关疲劳（CRF）是癌症患者报告的最常见症状之一。这项随机试验调查了氨基酸果冻Inner Power（®）（IP）的疗效，IP是一种半固体、可口服的膳食补充剂，含有辅酶Q10和左旋肉碱，用于控制日本乳腺癌患者的CRF。
方法
接受化疗的CRF乳腺癌患者被随机分配，每天接受一次IP或常规护理，为期21天。主要终点是从第1天（基线）到第22天过去24小时内最严重疲劳水平的变化（简明疲劳量表[BFI]第3项评分）。次要终点包括总体疲劳评分（GFS；所有BFI项目的平均值）的变化、通过医院焦虑抑郁量表（HADS）评估的焦虑和抑郁、通过欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30）和EORTC乳腺癌特异性QLQ（EORTC QLQ-BR23）评估的生活质量，以及不良事件。
结果
59名患者参与了该研究，其中57名纳入疗效分析。患者中位年龄为50岁。干预组和对照组在最严重疲劳水平、GFS和当前疲劳感的变化上有显著差异，而两组之间平均疲劳感的变化无显著差异。两组之间HADS、EORTC QLQ-C30和EORTC QLQ-BR23评分无显著差异。未观察到严重不良事件。
结论
IP可能控制乳腺癌患者的中重度CRF。
试验注册
本研究在大学医院医学信息网络临床试验注册中心（UMIN-CTR）的注册号为UMIN000008646。
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