EFFICACY OF TRICYCLICS IN TREATING CANCER PAIN

这项试验的目的是调查假设， 阿米替林或地昔帕明（三环抗抑郁药， 显著去甲肾上腺素能再摄取抑制）具有显著的镇痛作用 作为辅助治疗的性质，在治疗癌症患者中度 尽管进行了优化治疗，但患者仍感到无法接受的疼痛 毒品 在三年的时间里，300名中度至 这项为期10周的研究正在征集严重疼痛。 的剂量 研究药物将在6周内以中等抗- 剂量为150 mg/天。 将监测阿片剂剂量， 如果需要的话调整。 主要结局指标将是一个二分的 镇痛结局变量，将根据以下组合创建 每位患者每日疼痛强度视觉模拟评分的变化 （VAS-PI）和每个患者阿片剂量的变化。 次要结局 测量将包括情绪评分（身体/神经检查）。 在 此外，将抽取血液样本以评价镇痛是否相关 抗氧化剂的血液水平。 来确定一个可能的预测模型 对于可能的应答者，将作为队列研究对数据进行重新分析。 这项研究的结果将对癌症的护理产生重大影响。 通过为哪些患者群体提供具体的指导， 都能从这种疗法中获益

The purpose of this trial is to investigate the hypothesis that amitriptyline or desipramine (tricyclic antidepresants which have substantial noradrenergic re-uptake inhibition) have significant analgesic properties as adjuvant therapy in treating cancer patients with moderate pain that the patients feel is unacceptable despite optimized treatment with narcotics. Over the three year period, 300 patients with moderate to severe pain are being solicited for this 10 week study. The dose of the study drugs will be titrated upward over 6 weeks in the mid-range anti- depressant dose of 150 mg/day. The opiate dose will be monitored and adjusted if needed. The primary outcome measure will be a dichotomous analgesic outcome variable, which will be created from a combination of changes in each patients's daily Visual Analogue Score for pain intensity (VAS-PI) and changes in each patients opiate dose. Secondary outcome measures will include mood score (Physical/ Neurological Exam). In addition, blood samples will be drawn to evaluate if analgesia is related to anti-depressant blood levels. To determine a possible prediction model for the likely responders, the data will be reanalyzed as a cohort study. The results of this study will substantially impact on the care of cancer pain by either providing specific guidance for which groups of patients stand to benefit from this therapy.