一项关于安非他酮治疗癌症相关疲劳的随机安慰剂对照试验：研究设计和程序。
A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.
机构信息
Moffitt Cancer Center, Tampa, FL, USA.
Moffitt Cancer Center, Tampa, FL, USA.
出版信息
Contemp Clin Trials. 2020 Apr;91:105976. doi: 10.1016/j.cct.2020.105976. Epub 2020 Mar 5.
BACKGROUND
Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS
A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION
This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.
背景
癌症相关疲劳是一个严重的问题，与生活质量差有关。行为干预包括运动和认知行为疗法，但幸存者可能不愿意或无法采用这些方法。药物干预（如选择性 5-羟色胺再摄取抑制剂）的效果并不理想。一种潜在的治疗方法是抗抑郁药安非他酮，它是一种去甲肾上腺素和多巴胺再摄取抑制剂，既能针对炎症，又能针对下丘脑-垂体-肾上腺轴。目前的研究旨在严格测试安非他酮治疗癌症相关疲劳的疗效和耐受性。
方法
一项随机、双盲、安慰剂对照试验将研究安非他酮对癌症相关疲劳的影响。该试验将通过罗切斯特大学医学中心（URMC）国家癌症研究所社区肿瘤学研究计划（NCORP）在全国范围内进行。无疾病的乳腺癌幸存者（n=422），在完成化疗和/或放疗 12-60 个月后，报告有明显疲劳，将被随机分为 1:1 组，分别接受安非他酮（300mg/天）或安慰剂治疗。结果将在基线和 12 周随访时进行评估。主要结局指标是疲劳，用慢性疾病治疗功能评估-疲劳量表（FACIT-F）进行测量。次要结局包括生活质量、抑郁和药物耐受性。探索性结局包括认知和症状学。癌症相关疲劳的潜在生物学机制和遗传调节因素也将被探讨。
讨论
这是我们所知的第一个安慰剂对照试验，评估安非他酮治疗癌症相关疲劳。阳性结果可能彻底改变癌症相关疲劳的治疗方法，因为安非他酮安全、廉价、广泛可用，而且可能比目前有限的治疗选择更能被许多患者耐受和接受。
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