The Effects of Soy Protein Supplementation on Post-Thoracotomy Pain

临床前研究表明，含有大豆蛋白的饮食可以抑制神经损伤后疼痛行为和痛觉过敏的发展，最近的数据表明，在炎症和骨癌疼痛模型中，富含大豆蛋白的饮食也有类似的保护作用。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，膳食中补充大豆可能会减轻骨关节炎引起的疼痛。这项拟议的研究将检验大豆蛋白补充剂是否能减轻肺部手术开胸后常见的疼痛。越来越多的人认识到，更严重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。采用两组（大豆蛋白补充与匹配的牛奶安慰剂补充）设计，接受选择性大开胸肺叶切除术的患者将被随机分配到这两个治疗组中的一个。患者将在开胸前2-3天开始服用大豆/安慰剂补充剂，并继续每天服用补充剂24周。可行性/试点研究将检查大豆补充对术后三个阶段的结果指标的影响：1)术后立即期；2)术后2-12周。在这项初步研究中，疼痛是主要的结果领域，测量将包括疼痛严重程度评分和止痛药使用。功能和生活质量是次要的结果域，测量将包括疼痛对日常活动、睡眠和健康相关的生活质量的干扰。在整个研究过程中，每两周收集一次结果测量数据。本研究旨在确定在开胸手术期间大豆补充剂的可行性和可接受性，确定在3个月的随访期间大豆补充剂的依从性水平，并估计大豆补充剂相对于安慰剂在减少开胸术后明显疼痛方面的效应大小。拟议的研究将为开展这样一项更大规模的随机试验提供必要的基础，以评估开胸术后补充大豆蛋白减轻疼痛的效果。这项研究将检验含有大豆蛋白的补充剂是否能减轻患者在开胸手术后的疼痛，开胸手术是治疗肺部肿瘤的一种常见手术。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。大豆对疼痛和使用止痛药的影响将被确定，以及在这些情况下患者的可接受性。

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.