The Effects of Soy Protein Supplementation on Post-Thoracotomy Pain

描述（由申请人提供）：临床前研究表明，含大豆的饮食抑制神经损伤后出现的疼痛行为和痛觉过敏的发展，最近的数据表明，高大豆蛋白饮食在炎症和骨癌疼痛模型中具有类似的保护作用。很少有研究直接研究含大豆饮食对人类疼痛敏感性的影响，但最近的一项随机临床试验表明，饮食中补充大豆可能会减少骨关节炎引起的疼痛。这项拟议中的研究将检查大豆蛋白补充剂是否能减少肺部手术开胸后常见的疼痛。越来越多的人认识到，更大的急性疼痛会导致组织愈合后的持续疼痛，这强调了确定可行策略的重要性，包括非药物和药物，以减少与手术相关的急性疼痛。使用2组（大豆蛋白补充剂与匹配的牛奶安慰剂补充剂）设计，接受择期开胸肺叶切除术的患者将被随机分配至这两个治疗组之一。患者将在开胸手术前2-3天开始开始服用大豆/安慰剂补充剂，并继续每天食用补充剂，持续另外24周。可行性/试点研究将在三个术后时间段内检查大豆补充剂对结局指标的影响：1）术后即刻; 2）术后2-12周。疼痛是本项初步研究中关注的主要结局领域，测量将包括疼痛严重程度评级和止痛药使用。功能和生活质量是关注的次要结局领域，测量将包括疼痛相关的日常活动干扰、睡眠和健康相关的生活质量。在整个研究期间，每两周收集一次结局指标。该研究旨在确定在开胸手术前后补充大豆的可行性和可接受性，确定在3个月的随访期间坚持补充大豆的水平，并估计补充大豆相对于安慰剂在减少开胸手术后显著疼痛方面的效果大小。这项拟议的研究将提供必要的基础，以走向这样一个更大的随机试验，以评估大豆蛋白补充剂在开胸手术后减轻疼痛的作用。这项研究将检查含有大豆蛋白的补充剂是否能减少开胸手术后患者的疼痛，开胸手术是肺肿瘤的常见手术。研究参与者将在手术前2-3天和手术后3个月随机服用大豆蛋白或牛奶蛋白补充剂。将确定大豆对疼痛和止痛药使用的影响，以及在这些条件下患者对补充剂的可接受性。

DESCRIPTION (provided by applicant): Preclinical studies indicate that soy-containing diets suppress the development of pain behaviors and hyperalgesia seen following nerve injury and recent data indicate a similar protective effect of a diet high in soy protein in inflammatory and bone cancer pain models. Very few studies have directly studied the effects of soy-containing diets on pain sensitivity in humans, but one recent randomized clinical trial suggests that dietary soy supplementation may reduce pain due to osteoarthritis. The proposed study will examine whether a soy protein supplement reduces the pain commonly experienced following thoracotomy for lung surgery. The growing recognition that greater acute pain leads to persistent pain following tissue healing underscores the importance of identifying viable strategies, including both non-pharmacological as well as pharmacological, for reducing the acute pain associated with surgery. Using a 2 group (soy protein supplementation vs. matched milk placebo supplementation) design, patients undergoing elective major open thoracotomy for lobectomy will be randomly assigned to one of these two treatment groups. Patients will begin taking the soy/placebo supplement 2-3 days prior to thoracotomy and continue daily consumption of the supplement for an additional 24 weeks. The feasibility/pilot study will examine the effects of soy supplementation on outcome measures during three post-operative time periods: 1) the immediate post-operative period; and 2) during 2-12 weeks following surgery. Pain is the primary outcome domain of interest in this pilot study and measures will include pain severity ratings and pain medication use. Function and quality of life are the secondary outcome domains of interest and measures will include pain-related interference with daily activities, sleep, and health-related quality of life. Outcome measures will be collected bi-weekly throughout the study. The study aims to determine the feasibility and acceptability of soy supplementation in the period surrounding thoracotomy, determine level of adherence to soy supplementation over the 3-month period of follow-up, and estimate the effect size of soy supplementation relative to placebo in reducing significant pain following thoracotomy. The proposed study will provide the necessary groundwork to move towards such a larger randomized trial to evaluate the pain-reducing effects of soy protein supplementation following thoracotomy. This study will examine whether a supplement that contains soy protein reduces the pain patients experience following a thoracotomy, a common surgical procedure for lung tumors. Study participants will be randomized to take either a soy protein or milk protein supplement 2-3 days prior to and for 3 months following surgery. The effect of soy on pain and use of pain medications will be determined, as well as the acceptability of the supplement to patients under these conditions.