Methylphenidate for Fatigue in Advanced Cancer Patients

描述（申请人提供）：疲劳是晚期癌症患者最常见和最具破坏性的症状之一。缓解疲劳有可能大大提高晚期癌症患者的生活质量。不同的机制，直接或相互作用，影响大脑功能，造成疲劳的主观症状。我们小组和其他人之前的研究表明，哌醋甲酯是一种轻度中枢神经系统兴奋剂，能够改善对疲劳的主观感知。在进行疲劳和其他症状管理研究的过程中，我们确定患者发现研究护士每天打电话非常有益，这使我们假设护理电话可能通过减少与慢性疾病相关的不确定性，对疲劳和心理社会症状提供治疗效果。具体来说，我们假设与安慰剂相比，接受哌甲酯治疗的患者的疲劳和疲劳相关症状会得到改善，并且与接受标准治疗的患者相比，接受护理电话随访治疗的患者会经历更低的症状强度和更高的生活质量。我们还假设，与单独使用哌醋甲酯或护理电话对癌症相关疲劳的影响相比，哌醋甲酯加护理电话对减少疲劳有协同作用。为了验证这些假设，我们提出了一项随机、安慰剂对照的2周研究，在212例转移性或无法治愈的癌症患者中比较哌醋甲酯和安慰剂；药物组和安慰剂组的一半患者将被随机分配，每2天接受一次护理随访电话，而另一半随机样本将接受标准护理。

DESCRIPTION (provided by applicant): Fatigue is one of the most common and devastating symptoms in patients with advanced cancer. Alleviating fatigue has the potential to greatly improve the quality of life of patients with advanced cancer. Different mechanisms, directly or interactively, impact on brain function to cause the subjective symptom of fatigue. Previous research by our group and others suggests that methylphenidate, a mild central nervous system stimulant, is capable of improving the subjective perception of fatigue. In the process of conducting fatigue and other symptom management studies, we determined that patients found a daily phone call by a research nurse extremely beneficial, leading us to hypothesize that nursing phone calls might provide a therapeutic effect on fatigue and psychosocial symptoms by reducing uncertainty associated with chronic illness. Specifically, we hypothesize that fatigue and fatigue-related symptoms will improve in patients receiving methylphenidate as compared to a placebo and that patients receiving nursing telephone follow-up care will experience lower symptom intensity and higher quality of life as compared to those receiving standard care. We also hypothesize that there is a synergistic effect of methylphenidate plus nursing phone calls on the reduction of fatigue as compared to the effects of either methylphenidate or nursing phone calls alone on cancer-related fatigue. To test these hypotheses, we propose a randomized, placebo-controlled 2-week study in 212 patients with metastatic or incurable cancer comparing methylphenidate versus placebo; half of the patients in the drug arm and half in the placebo arm will be randomized to receive nursing follow-up phone calls every 2 days while the other half of the randomized sample will receive standard care.