Acupuncture Treatment of Pain in Pancreatic Cancer

描述(申请人提供)：背景：胰腺癌影响 每年大约有28,000名美国人。其中约85%-90% 当患者的疾病已经是当地晚期或 转移性的。在这一点上，中位生存期是三到六个月。治疗 胰腺癌本质上主要是姑息性的。疼痛控制通常是 最严重的挑战：胰腺有广泛的血液，淋巴和 神经供应，周围环绕着许多其他腹部器官。超过90 30%的晚期胰腺癌患者经历了中度到 剧烈的疼痛。有几种手术和非手术的方法可以缓解症状。 胰腺疼痛，包括阻断来自胰腺的传入疼痛纤维。 关于这些方法的有效性的数据有限，这些干预措施 倾向于仅在特定情况下使用。吉西他滨在肿瘤治疗中的应用 化疗或放射治疗可以减轻少数患者的疼痛。多数 患者需要鸦片类药物来控制疼痛，而且经常需要大剂量的药物 导致令人不快的镇静。基础和临床研究支持针灸 用于治疗疼痛。一项随机试验发现，针灸有助于 缓解非恶性胰腺疼痛，提示早期试验 针灸治疗胰腺癌疼痛是有必要的。 目的：评估针灸/穴位按压干预对糖尿病患者的影响。 胰腺癌患者的疼痛、镇静和阿片类药物治疗 经历中度到重度疼痛以：i)确定对照试验 以及ii)提供数据以帮助设计进一步的保证研究。 方法：最初，少数胰腺癌患者报告 无论是高度疼痛还是高度镇静，都将按顺序进行治疗 最终确定针灸处方和数据收集程序。我们 然后将在标准的两阶段II期设计中增加患者。病人 将接受四个疗程的标准化针灸治疗 介入穴位按压超过10天。疼痛、鸦片类药物和镇静剂会 在基线和治疗后进行为期三天的评估。病人将会是 如果他们报告了预先指定的水平，则被视为对治疗有反应 疼痛或镇静的改善。将招募10名患者。如果 少于两次经验答复的，审判将终止。否则，一个 将增加19名患者。第三阶段试验将被视为 如果总共有6个或更多响应，则保证；这与 30%的应答率。

DESCRIPTION (provided by applicant): BACKGROUND: Pancreatic cancer affects approximately 28,000 Americans a year. Approximately 85-90 percent of these patients are first diagnosed when their disease already is locally advanced or metastatic. AT this point, median survival is three to six months. Treatment of pancreatic cancer is predominantly palliative in nature. Pain control is often the most serious challenge: the pancreas has an extensive blood, lymphatic and nerve supply and is surrounded by numerous other abdominal organs. More than 90 percent of patients with advanced pancreatic cancer experience moderate to severe pain. Several surgical and non-operative procedures are used to palliate pancreatic pain, including blocking afferent pain fibers from the pancreas. Data on the efficacy of these approaches are limited and these interventions tend to be used only in select cases. Oncologic management with gemcitabine chemotherapy or radiotherapy reduces pain in a minority of patients. Most patients require opiates for pain control, and the high doses needed often cause undesirable sedation. Basic and clinical research supports acupuncture for the treatment of pain. A randomized trial found that acupuncture helps relieve non-malignant pancreatic pain, suggesting that an early phase trial of acupuncture for pancreatic cancer pain would be warranted. Objectives: To assess the effects of an acupuncture/acupressure intervention on pain, sedation and opiate medication in patients with pancreatic cancer experiencing moderate to severe pain to: i) determine whether controlled trials are warranted and ii) provide data to aid design of further warranted studies. Methods: Initially, a small number of pancreatic cancer patients reporting either high levels of pain or high levels of sedation will be treated in order to finalize the acupuncture prescription and the data collection procedures. We will then accrue patients in a standard two-stage, Phase II design. Patients will receive four sessions of a standardized acupuncture treatment with intervening acupressure over 10 days. Pain, opiate medication and sedation will be assessed for three days at baseline and post-treatment. Patients will be considered to have responded to treatment if they report a pre-specified level of improvement in either pain or sedation. Ten patients will be recruited. If less than two experience responses, the trial will be terminated. Otherwise, an additional 19 patients will be accrued. A Phase III trial will be deemed warranted if there are 6 or more responses in total; this is consistent with a 30 percent response rate.