The Effects of Soy Protein Supplementation on Post-Thoracotomy Pain

补充大豆蛋白对开胸术后疼痛的影响

• 批准号: 7614402
• 负责人: JENNIFER A HAYTHORNTHWAITE
• 金额: $ 22.14万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7614402
• 关键词: Absence of pain sensation; Ache; Acute; Acute Pain; Adherence; Adverse effects; Analgesics; Area; Behavioral; Benign; Burn injury; Chronic; Chronic disabling pain; Clinical Trials; Collection; Complication; Consumption; Data; Degenerative polyarthritis; Development; Diagnosis; Diet; Drops; Excision; Excretory function; Future; Genistein; Goals; Healed; Health; Human; Hyperalgesia; Individual; Inflammatory; Intervention; Investigation; Literature; Lobectomy; Logistics; Lung; Lung Neoplasms; Malignant Bone Neoplasm; Manuals; Measures; Metabolism; Methodology; Milk; Milk Proteins; Modeling; Morbidity - disease rate; Movement; Multi-Institutional Clinical Trial; Narcotics; Neuropathy; Operative Surgical Procedures; Outcome; Outcome Assessment; Outcome Measure; Pain; Pain management; Participant; Patients; Persistent pain; Pharmaceutical Preparations; Phase; Pilot Projects; Placebos; Postoperative Pain; Postoperative Period; Prevalence; Process; Proteins; Protocols documentation; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recruitment Activity; Relative (related person); Reporting; Research; Research Design; Sample Size; Sampling; Segmental Mastectomy; Severities; Site; Sleep; Soy Proteins; Subgroup; Supplementation; Surgical incisions; Testing; Thoracotomy; Time; Tissues; Treatment Protocols; Urine; cancer pain; clinical efficacy; cost; daidzein; design; diaries; equol; experience; follow-up; healing; health related quality of life; human study; inflammatory neuropathic pain; innovation; interdisciplinary approach; interest; nerve injury; pain behavior; pilot trial; pre-clinical; preclinical study; prevent; primary outcome; protective effect; secondary outcome; soy; urinary

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.

描述（由申请人提供）：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，富含大豆蛋白的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轻骨关节炎引起的疼痛。拟议的研究将检查大豆蛋白补充剂是否可以减轻开胸肺手术后常见的疼痛。人们越来越认识到，更大的急性疼痛会导致组织愈合后的持续性疼痛，这突显了确定可行策略（包括非药物和药物）以减少与手术相关的急性疼痛的重要性。采用 2 组（补充大豆蛋白与补充匹配的牛奶安慰剂）设计，接受选择性开胸肺叶切除术的患者将被随机分配到这两个治疗组之一。患者将在开胸术前 2-3 天开始服用大豆/安慰剂补充剂，并在接下来的 24 周内继续每天服用该补充剂。可行性/试点研究将检查大豆补充剂对术后三个时期的结果指标的影响：1）术后即刻； 2) 手术后 2-12 周内。疼痛是本试点研究关注的主要结果领域，测量措施将包括疼痛严重程度评级和止痛药物的使用。功能和生活质量是次要结果领域，衡量标准将包括与疼痛相关的对日常活动、睡眠和健康相关生活质量的干扰。在整个研究过程中，将每两周收集一次结果测量结果。该研究旨在确定开胸手术期间补充大豆的可行性和可接受性，确定在 3 个月的随访期间对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果大小。拟议的研究将为进行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的减轻疼痛的效果。这项研究将检验含有大豆蛋白的补充剂是否可以减轻患者在开胸手术（肺部肿瘤的常见外科手术）后经历的疼痛。研究参与者将被随机分配在手术前 2-3 天和手术后 3 个月内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物使用的影响，以及在这些情况下患者对补充剂的可接受性。