Characterization of and Treatment for Chemotherapy Neuropathy

描述（由申请人提供）：项目总结癌症化疗诱导的周围神经病变（CIN）是癌症治疗最常见的神经系统并发症。它是最常见的化疗药物（CTX）的主要副作用。虽然流行病学研究有限，但临床经验表明，CIN发生在很大比例的患者中，并对患者的功能和生活质量产生重大影响。此外，目前还没有有效的CIN治疗方法。这项研究将分两部分进行。在第1部分中，使用已完成CTX的CIN患者（n=400）和非CIN患者（n=200）的样本，比较表型（即，感觉特征、运动特征、情绪、并发症状、平衡、生活质量）和基因型特征（即，候选基因研究）将被评估。在第2部分中，基于我们小组最近的工作，即证明光子刺激在改善疼痛性糖尿病周围神经病变患者的感觉和生活质量方面的疗效，我们将进行一项初步研究，以确定光子刺激与安慰剂相比在改善已完成CTX治疗的CIN肿瘤患者的轻触感觉、疼痛强度和疼痛质量方面的效应量。此外，我们将确定治疗方案的可行性和光子刺激在CIN患者中的安全性。患者将在14天内接受8次光子刺激或安慰剂治疗。将在基线和第2、4、6和8天每次治疗前进行主观和客观测量。该初步研究的数据将用于确定是否需要对CIN进行大规模的光子刺激随机临床试验。

DESCRIPTION (provided by applicant): Project Summary Cancer chemotherapy-induced peripheral neuropathy (CIN) is the most prevalent neurological complication of cancer treatment. It is a major side effect of the most frequently administered chemotherapy (CTX) drugs. While epidemiologic studies are limited, clinical experience suggests that CIN occurs in a large percentage of patients and has a significant impact on patients' ability to function and quality of life. In addition, effective treatments for CIN are not available at the present time. This study will be conducted in two parts. In Part 1, using a sample of patients with (n=400) and without (n=200) CIN who have completed CTX, differences in phenotypic (i.e., sensory characteristics, motor characteristics, mood, concurrent symptoms, balance, quality of life) and genotypic characteristics (i.e., candidate gene studies) will be evaluated. In Part 2, based on recent work from our group that demonstrated the efficacy of photon stimulation in improving sensation and quality of life in patients with painful diabetic peripheral neuropathy, we will conduct a pilot study to determine effect sizes for the effects of photon stimulation compared to placebo in improving light touch sensation, pain intensity, and pain qualities in oncology patients with CIN who have completed CTX. In addition, we will determine the feasibility of the treatment protocol and the safety of photon stimulation in patients with CIN. Patients will be treated with eight photon stimulation or placebo treatments over a period of 14 days. Subjective and objective measures will be done at baseline and prior to each of the treatments on days 2, 4, 6, and 8. Data from this pilot study will be used to determine if a large scale randomized clinical trial of photon stimulation is warranted for CIN.