Acupuncture to Prevent Chemotherapy Dose Reduction

针灸预防化疗剂量减少

基本信息

批准号：
8427599
负责人：
Ting Bao
金额：
$ 16.44万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-02-01 至 2015-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8427599
关键词：
Acupuncture procedure Adjuvant Adjuvant Chemotherapy Adverse effects Cancer Center Cancer Patient Chinese Traditional Medicine Clinical Clinical Research Clinical Trials Colon Carcinoma Colorectal Cancer Controlled Clinical Trials Data Disease Dose Dose-Limiting Effectiveness Foundations Future Goals Lead Light Maryland Measures Mediating Multiple Myeloma Neoadjuvant Therapy Nerve Growth Factors Neural Conduction Neurohormones Neuropathy Neurotoxins Operative Surgical Procedures Pain Patients Peripheral Nervous System Diseases Phase Pilot Projects Placebo Control Placebos Preventive Process Questionnaires Randomized Relapse Relative (related person)Role Sample Size Schedule Serum Side Symptoms Techniques Testing Universities base cancer therapy chemotherapy cytokine design effective therapy experience improved malignant breast neoplasm minimally invasive neurotoxic neurotoxicity neurotrophic factor oncology prevent public health relevance randomized placebo controlled trial response standard care treatment planning

项目摘要

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.

描述（由申请人提供）：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能会导致无复发生存率和总生存率显着下降。我们的初步数据表明，针灸可显着减轻 CIPN 神经毒性症状，改善神经传导研究，并防止因 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 NGF 来预防 CIPN 恶化，并提高接受神经毒素化疗的乳腺癌和结直肠癌患者的化疗耐受性。我们的目标是确定针灸在新辅助和辅助治疗的乳腺癌和结直肠癌患者中减轻 CIPN 症状和预防 CIPN 引起的化疗剂量减少的有效性。我们将进行一项 60 名患者随机、安慰剂对照试验，以 1) 确定针灸对减少化疗剂量的效果，2) 确定针灸对预防 CIPN 恶化的效果，以及 3) 确定其中一种机制针灸治疗 CIPN 的研究进展.我们提出的研究将把针灸融入肿瘤学实践中，以改善患者对标准化疗的耐受性。我们的研究有可能找到一种有效的 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，从而提高他们的无复发生存率和总生存率。