Acupuncture and aromatase inhibitor ralated arthralgia

描述（由申请方提供）：关节痛、关节疼痛是接受芳香化酶抑制剂（AI）作为辅助治疗的绝经后乳腺癌幸存者的主要症状负担来源。来自大型临床试验的数据表明，人工智能会使关节痛的发生率增加20%至30%。最近的一项研究发现，在门诊肿瘤学实践中，47%的AI用户报告了AI相关的关节痛。关节痛不仅损害日常功能，还可能导致不依从和过早停止治疗，这两种情况都严重削弱了人工免疫预防乳腺癌复发的有效性。作为一种有前途的非药物性疼痛管理方法，针灸刺激中枢神经系统产生内源性阿片类药物，由于雌激素耗竭，AI使用者的内源性阿片类药物可能减少。虽然一些临床试验已经证明了针灸对普通人群膝关节骨关节炎的疗效，但没有随机对照试验研究其对AI相关关节痛的影响。在我们现有的试点工作的基础上，这项R21提案旨在汇集一个多学科的研究人员团队，在75名绝经后I-III期乳腺癌妇女中严格和系统地评估为期8周的电针（EA）干预对AI相关关节痛的影响，这些妇女已完成主要治疗（手术，化疗和放疗），目前正在接受AI治疗。这将在一项3组平行、随机、对照试验中完成，该试验比较了EA与等待列表对照（WLC）和安慰剂EA（使用Streitberger非穿透性针输送）。我们的具体目标是：1）通过比较针刺和WLC来确定针刺减轻AI相关关节痛的总体效果; 2）估计verum和安慰剂EA之间的效应大小和方差，以用于增强随访R 01;和3）为了阐明由针灸期望量表测量的反应期望与对针灸的临床反应（定义为疼痛减轻百分比）之间的关系，干预的结束。上述具体目标将使我们能够生成必要的数据，以计划一个明确的R 01，旨在确定特定针灸针刺减少AI相关关节痛的疗效。 公共卫生相关性：由于关节痛是一个主要的症状负担，对许多服用芳香化酶抑制剂的乳腺癌幸存者产生负面影响，因此需要确定和测试有效的干预措施。患有乳腺癌的妇女对使用非药物方法进行症状管理广泛感兴趣。因此，针对这一应用的针灸研究有可能提供急需的证据，证明针灸可以减轻疼痛，改善数十万妇女的生活质量。

DESCRIPTION (provided by applicant): Arthralgia, joint pain, is emerging as a major source of symptom burden in postmenopausal breast cancer survivors receiving Aromatase Inhibitors (AIs) as adjuvant therapy. Data from large clinical trials suggest that AIs increase the rate of arthralgia by 20 to 30%. A recent study found that 47% AI users in an outpatient oncology practice reported AI-related arthralgia. Arthralgia not only impairs daily functions but can also lead to non-adherence and premature treatment discontinuation, both of which seriously diminish the effectiveness of AIs for prevention of breast cancer recurrence. As a promising non-pharmacological approach to pain management, acupuncture stimulates the central nervous system's production of endogenous opioids, which may be decreased in AI users because of estrogen depletion. While several clinical trials have demonstrated the efficacy of acupuncture for osteoarthritis of the knee in the general population, no randomized controlled trial has investigated its effects on AI-related arthralgia. Building on our existing pilot work, this R21 proposal seeks to bring together a multidisciplinary team of investigators to rigorously and systematically evaluate the effects of an 8-week of electro-acupuncture (EA) intervention for AI-related arthralgia among 75 postmenopausal women with stage I-III breast cancer, who have completed primary treatment (surgery, chemotherapy, and radiotherapy), and who are currently receiving AI therapy. This will be accomplished in a 3-arm parallel, randomized, controlled trial comparing EA against wait- list control (WLC) and placebo EA (delivered using the Streitberger non-penetrating needles). Our specific aims are: 1) To determine the overall effect of acupuncture for reducing AI-related arthralgia by a comparison between acupuncture and WLC; 2) To estimate the effect size and variance between verum and placebo EA to be used to power the follow-up R01; and 3) To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale and clinical response to acupuncture defined as percent reduction of pain at the end of the intervention. The above specific aims will allow us to generate the necessary data to plan a definitive R01 that aims to establish the efficacy of specific acupuncture needling for reducing AI-related arthralgia. PUBLIC HEALTH RELEVANCE: Because arthralgia is a major symptom burden negatively impacting many breast cancer survivors taking aromatase inhibitors, effective interventions need to be identified and tested. Women with breast cancer are widely interested in using non-pharmacological approaches for symptom management. Therefore, the study of acupuncture for this application has the potential to provide the much needed evidence that acupuncture may reduce pain and improve quality of life among hundreds of thousands of women.