Acupuncture to Prevent Chemotherapy Dose Reduction

描述(申请人提供)：化疗最有害的副作用之一是化疗引起的周围神经病变(CIPN)，这是许多化疗药物的一种常见的、无效的和剂量限制的副作用，目前还没有有效的治疗方法。剂量强度的小幅降低可以导致无复发生存率和总体生存率的显着下降。我们的初步数据显示，针刺显著减轻了CIPN的神经毒性症状，改善了神经传导研究，并阻止了CIPN导致的化疗剂量减少。我们的中心假设是，针灸可以通过增加神经生长因子来预防乳腺癌和结直肠癌患者接受神经毒素化疗时CIPN的恶化，并提高化疗的耐受性。我们的目标是确定针灸在新辅助和辅助环境下减轻CIPN症状和预防CIPN引起的乳腺癌和结直肠癌患者化疗剂量减少的有效性。我们将进行一项先导性、随机、安慰剂对照试验，以1)确定针刺对减少化疗剂量的作用，2)确定针刺预防CIPN恶化的作用，3)确定针刺治疗CIPN的机制之一。我们提出的研究将把针灸与肿瘤学实践相结合，以提高患者对标准化疗的耐受性。我们的研究有可能为CIPN寻找一种有效的非药物治疗方法，并提高癌症患者对标准化疗方案的耐受性，从而提高他们的无复发生存率和总生存率。

DESCRIPTION (provided by applicant): One of the most harmful side effects of chemotherapy is chemotherapy-induced peripheral neuropathy (CIPN), a common, disabling and dose-limiting side effect of many chemotherapy agents for which there is no effective treatment. A small reduction in dose intensity can cause a significant decrease in relapse-free survival and overall survival. Our preliminary data showed that acupuncture significantly reduced CIPN neurotoxicity symptoms, improved nerve conduction study, and prevented chemotherapy dose reduction due to CIPN. Our central hypothesis is that acupuncture can prevent worsening of CIPN and improve tolerance of chemotherapy in breast and colorectal cancer patients receiving neurotoxin chemotherapy through increasing NGF. Our goal is to determine the effectiveness of acupuncture in reducing CIPN symptoms and preventing chemotherapy dose reduction caused by CIPN in breast and colorectal cancer patients in the neoadjuvant and adjuvant settings. We will conduct a pilot, 60- patient, randomized, placebo-controlled trial to 1) determine the effect f acupuncture on chemotherapy dose reduction, 2) determine the effect of acupuncture on prevent worsening of CIPN, and 3) identify one of the mechanisms of acupuncture in treating CIPN. Our proposed study will integrate acupuncture into oncology practice to improve to improve patients' tolerance of standard chemotherapy. Our study has the potential to identify an effective non-pharmacological treatment for CIPN and to improve cancer patients' tolerance of standard chemotherapy schedule and subsequently improve their relapse-free survival and overall survival.