Acupuncture and aromatase inhibitor ralated arthralgia

描述（由申请人提供）：关节痛，关节痛，正在成为绝经后乳腺癌幸存者接受芳香酶抑制剂（AIs）作为辅助治疗的主要症状负担来源。来自大型临床试验的数据表明，ai使关节痛的发生率增加了20%至30%。最近的一项研究发现，在门诊肿瘤学实践中，47%的人工智能用户报告了与人工智能相关的关节痛。关节痛不仅影响日常功能，还可能导致不依从和过早停止治疗，这两种情况都严重降低了AIs预防乳腺癌复发的有效性。作为一种很有前途的非药物治疗疼痛的方法，针灸刺激中枢神经系统产生内源性阿片样物质，而在人工智能使用者中，由于雌激素的消耗，这种物质可能会减少。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调查其对人工智能相关关节痛的影响。基于我们现有的试点工作，本R21提案旨在汇集一个多学科研究团队，对75名已完成初级治疗（手术、化疗和放疗）并目前正在接受人工智能治疗的绝经后I-III期乳腺癌妇女进行为期8周的电针（EA）干预治疗人工智能相关关节痛的效果进行严格和系统的评估。这将在一项3臂平行、随机、对照试验中完成，该试验将EA与等候名单对照（WLC）和安慰剂EA（使用Streitberger非穿透针）进行比较。我们的具体目的是：1)通过针灸与WLC的比较，确定针灸减轻人工智能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，以支持随访R01；3)阐明针灸期望量表测量的反应期望与针灸临床反应之间的关系，针灸临床反应定义为干预结束时疼痛减轻的百分比。上述具体目标将使我们能够生成必要的数据来计划一个明确的R01，旨在确定特定针灸对减少人工智能相关关节痛的疗效。

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.