The Effects of Soy Protein Supplementation on Post-Thoracotomy Pain

描述(申请人提供)：临床前研究表明，含大豆的饮食可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，在炎症和骨癌疼痛模型中，高大豆蛋白饮食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，饮食大豆补充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手术后常见的疼痛。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性疼痛，这突显了确定可行的策略的重要性，包括非药物和药物策略，以减少与手术相关的急性疼痛。采用2组(大豆蛋白补充剂与匹配牛奶安慰剂补充剂)设计，接受择期开胸肺叶切除术的患者将随机分配到这两个治疗组中的一个。患者将在开胸手术前2-3天开始服用大豆/安慰剂补充剂，并继续每天服用该补充剂24周。这项可行性/试点研究将考察大豆补充剂在术后三个时间段对结果测量的影响：1)手术后立即时间段；2)手术后2-12周期间。疼痛是这项先导研究关注的主要结果领域，衡量标准将包括疼痛严重程度评级和止痛药使用。功能和生活质量是感兴趣的次要结果领域，衡量标准将包括与疼痛相关的对日常活动、睡眠和与健康相关的生活质量的干预。结果测量将在整个研究过程中每两周收集一次。这项研究旨在确定在开胸手术期间补充大豆的可行性和可接受性，确定在3个月的随访期内补充大豆的依从性，并估计与安慰剂相比，大豆补充在减轻开胸手术后显著疼痛方面的效果。这项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，以评估开胸手术后补充大豆蛋白的止痛效果。这项研究将研究含有大豆蛋白的补充剂是否可以减少开胸手术后患者的疼痛体验，开胸手术是肺部肿瘤的常见外科手术。研究参与者将随机在手术前2-3天和术后3个月服用大豆蛋白或牛奶蛋白补充剂。大豆对疼痛的影响和止痛药的使用将被确定，以及在这些情况下患者对补充剂的接受程度。

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.