Department of Psychiatry, University of Connecticut Health Center, 10 Talcott Notch Road, Farmington, CT, USA.
Support Care Cancer. 2012 Aug;20(8):1745-53. doi: 10.1007/s00520-011-1268-8. Epub 2011 Sep 27.
Fatigue is a common and often disabling symptom for cancer patients. To date, no pharmacological interventions have shown reliable efficacy in treatment of cancer-related fatigue (CF). Thyrotropin-releasing hormone (TRH), a key regulator of homeostasis, exerts arousing and analeptic actions in instances of behavioral depression. In the present pilot, randomized, placebo-controlled, crossover study, we investigated the efficacy and safety of TRH as a treatment for CF.
Patients with cancer experiencing significant fatigue without medically reversible causes were enrolled in this study. The primary outcome measure was the visual analog scale for energy (VAS-E) assessed at 3, 7, and 24 h post-study medication administration. Secondary outcome measures included the profile of mood states (POMS) questionnaire, a 6-min walking test, the hospital anxiety and depression scale, the Leeds sleep questionnaire, and assessment of quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Eight patients completed the study. TRH administration was associated with significant improvement in fatigue level as measured by the VAS-E, the fatigue and vigor subscales of the POMS, and the fatigue subscale of FACIT-F (p < 0.05). It was also associated with a positive impact on quality of life. TRH administration was associated with transient increases in blood pressure and heart rate.
TRH administration was efficacious, safe, and tolerable in the treatment of CF with a positive impact on quality of life. These results provide a crucial impetus for pursuing TRH therapeutics to treat CF.
疲劳是癌症患者常见且常导致残疾的症状。迄今为止，尚无药物干预措施显示出对癌症相关疲劳（CF）治疗的可靠疗效。促甲状腺素释放激素（TRH）是一种内稳态的关键调节剂，在行为抑郁的情况下发挥兴奋和苏醒作用。在本先导、随机、安慰剂对照、交叉研究中，我们研究了 TRH 作为 CF 治疗的疗效和安全性。
患有癌症且出现无医学可逆原因的明显疲劳的患者被纳入本研究。主要结局测量指标是研究药物给药后 3、7 和 24 小时评估的能量视觉模拟量表（VAS-E）。次要结局测量指标包括心境状态问卷（POMS）、6 分钟步行测试、医院焦虑和抑郁量表、利兹睡眠问卷以及使用慢性疾病治疗疲劳功能评估（FACIT-F）评估生活质量。
8 名患者完成了研究。TRH 给药与 VAS-E、POMS 的疲劳和活力子量表以及 FACIT-F 的疲劳子量表测量的疲劳水平的显著改善相关（p < 0.05）。它也与生活质量的积极影响相关。TRH 给药与血压和心率的短暂升高相关。
TRH 给药在治疗 CF 方面是有效、安全且耐受良好的，对生活质量有积极影响。这些结果为寻求 TRH 治疗 CF 提供了至关重要的动力。
