Acupuncture and aromatase inhibitor ralated arthralgia

描述(申请人提供)：关节痛，关节痛，正在成为接受芳香酶抑制剂(AIS)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，人工智能使关节疼痛的发生率增加了20%到30%。最近的一项研究发现，在一家肿瘤科门诊诊所中，47%的人工智能用户报告了与人工智能相关的关节痛。关节痛不仅损害日常功能，还可能导致不坚持治疗和过早停止治疗，这两种情况都严重削弱了人工智能预防乳腺癌复发的有效性。作为一种有前景的非药理学疼痛控制方法，针灸刺激中枢神经系统内源性阿片类药物的产生，而人工智能使用者的内源性阿片类药物可能会因为雌激素耗尽而减少。虽然一些临床试验已经证明了针灸在普通人群中对膝骨性关节炎的疗效，但还没有随机对照试验调查其对人工智能相关关节痛的影响。在我们现有试点工作的基础上，这项R21提案寻求聚集一个多学科的研究团队，严格和系统地评估为期8周的电针(EA)干预对75名绝经后I-III期乳腺癌患者的疗效，这些女性已经完成了初级治疗(手术、化疗和放射治疗)，目前正在接受AI治疗。这将在一项三臂平行、随机、对照试验中完成，比较电针与等待名单对照(WLC)和安慰剂电针(使用Streitberger非穿透针)。我们的具体目标是：1)通过针灸和WLC之间的比较，确定针灸对减轻AI相关关节痛的整体效果；2)估计Verum和安慰剂EA之间用于支持后续R01的效果大小和方差；以及3)阐明通过针灸预期量表测量的反应预期与干预结束时定义为疼痛减少百分比的临床反应之间的关系。上述具体目标将使我们能够产生必要的数据，以计划最终的R01，旨在建立特定针刺对减少AI相关关节痛的疗效。 公共卫生相关性：由于关节痛是一种主要症状负担，对许多服用芳香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。患有乳腺癌的女性对使用非药物方法进行症状管理非常感兴趣。因此，针灸应用的研究有可能提供急需的证据，证明针灸可以减轻疼痛，提高数十万女性的生活质量。

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.