Acupuncture to Prevent Chemotherapy Dose Reduction

描述（由申请人提供）：化疗最有害的副作用之一是化疗诱导的周围神经病变（CIPN），这是许多化疗药物的常见、致残和剂量限制性副作用，目前尚无有效治疗方法。剂量强度的小幅降低可导致无复发生存期和总生存期的显著降低。我们的初步数据显示，针刺显著减轻CIPN神经毒性症状，改善神经传导研究，并防止因CIPN而减少化疗剂量。我们的中心假设是，针灸可以防止CIPN的恶化，并通过增加神经生长因子，提高乳腺癌和结直肠癌患者接受神经毒素化疗的耐药性。我们的目标是确定针灸在减少CIPN症状和预防CIPN引起的乳腺癌和结直肠癌患者在新辅助和辅助设置化疗剂量减少的有效性。我们将进行一项试点，60例患者，随机，安慰剂对照试验，以1）确定针灸对化疗剂量减少的影响，2）确定针灸对预防CIPN恶化的影响，3）确定针灸治疗CIPN的机制之一。我们的研究将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。我们的研究有可能确定一种有效的CIPN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，从而提高其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.