Characterization of and Treatment for Chemotherapy Neuropathy

项目简介：癌症化疗引起的周围神经病变(CIN)是癌症治疗中最常见的神经系统并发症。这是最频繁使用的化疗(CTX)药物的主要副作用。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，并对患者的功能能力和生活质量产生重大影响。此外，目前还没有有效的治疗CIN的方法。这项研究将分两部分进行。在第一部分中，将使用完成CTX的CIN患者(n=400)和非CIN患者(n=200)的样本，评估表型(即感觉特征、运动特征、情绪、并发症状、平衡、生活质量)和基因特征(即候选基因研究)的差异。在第二部分，基于我们团队最近的工作，证明了光子刺激在改善疼痛的糖尿病周围神经病变患者的感觉和生活质量方面的有效性，我们将进行一项先导性研究，以确定与安慰剂相比，光子刺激在改善完成CTX的CIN肿瘤患者的光触觉、疼痛强度和疼痛质量方面的效果大小。此外，我们还将确定CIN患者治疗方案的可行性和光子刺激的安全性。患者将接受为期14天的八光子刺激或安慰剂治疗。主观和客观测量将在第2、4、6和8天的基线和治疗前进行。这项先导性研究的数据将用于确定是否有必要对CIN进行大规模随机临床试验。 公共卫生相关性：项目叙述化疗后手脚麻木、刺痛和疼痛(也称为化疗诱导的神经病(CIN))是肿瘤科患者的常见问题。然而，关于患者为什么会发生神经病变以及它如何影响他们的情绪、功能能力和生活质量，还需要更多的信息。此外，目前还没有针对这个问题的有效治疗方法。这项研究将分两部分进行。在第一部分中，将对完成化疗并发生或没有发生CIN的患者进行评估，以确定为什么有些患者会发生CIN，而另一些患者则不会发生CIN。此外，还将通过比较患者对这些重要预后指标的报告来评估CIN对患者情绪、功能和生活质量的影响。此外，还将对有助于或防止CIN发生的遗传标记进行评估。这项研究的第二部分将测试一种名为光子刺激(也称为红外线疗法)的新疗法与安慰剂疗法在改善CIN肿瘤学患者足部感觉方面的效果。

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. PUBLIC HEALTH RELEVANCE: Project Narrative Numbness, tingling, and pain in the hands and feet following the administration of chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in oncology patients. However, more information is needed on why patients develop neuropathy and how it impacts their mood, ability to function, and their quality of life. In addition, effective treatments for this problem are not available at the present time. This study will be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did not develop CIN will be evaluated to determine why some patients do and other patients do not develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life will be evaluated by comparing patients' reports on these important outcome measures. In addition, genetic markers that contribute to or protect against the development of CIN will be evaluated. Part 2 of this study will test the effects of a new treatment called photon stimulation (also called infrared light therapy) compared to placebo treatment to improve sensations in the feet of oncology patients with CIN.