Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults with Cancer: A two arm pilot study

青少年和年轻人癌症患者化疗引起的疼痛性周围神经病变的创新治疗：一项两臂试点研究

• 批准号: 10560600
• 负责人: Salahadin Abdi
• 金额: $ 18.56万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-02 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10560600
• 关键词: Acupuncture Therapy; Address; Adolescent; Adolescent and Young Adult; Adolescent and young adult cancer patients; Adult; Adverse effects; Affect; Age; Analgesics; Antidepressive Agents; Antiepileptic Agents; Blinded; Brief Pain Inventory; Cessation of life; Chemotherapy-induced peripheral neuropathy; Child; Child Care; Clinic; Clinical; Clinical Management; Clinical Trials; Clinical assessments; Common Terminology Criteria for Adverse Events; Constipation; Control Groups; Controlled Clinical Trials; Cutaneous; Data; Data Collection; Devices; Drug usage; Effectiveness; Elderly; Electric Stimulation; European Organization for Research and Treatment of Cancer; Evaluation; Experimental Designs; Functional disorder; Goals; Italy; Knowledge; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Medication Management; Motor; Nerve; Nervous System Trauma; Neurologic; Neurologist; Neuropathy; Numbness; Opioid; Outcome Measure; Pain; Pain management; Patient Outcomes Assessments; Patients; Peripheral Nervous System; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Physical Function; Physical Performance; Physical assessment; Pilot Projects; Platinum Compounds; Procedures; Publishing; Quality of life; Questionnaires; Randomized; Reporting; Research; Safety; Sedation procedure; Sensory; Survival Rate; Symptoms; Techniques; Testing; Transcutaneous Electric Nerve Stimulation; United States; United States Food and Drug Administration; Ventilatory Depression; Vinca Alkaloids; Vincristine; Waiting Lists; Walking; Yoga; addiction; arm; cancer care; cancer pain; cancer type; chemotherapy; effective therapy; efficacy evaluation; experience; improved; innovation; negative affect; novel; pain reduction; pain scale; painful neuropathy; primary outcome; prospective; public health relevance; secondary outcome; side effect; treatment duration

PROJECT SUMMARY/ABSTRACT An estimated one in five children in the United States has cancer. Fortunately, the 5-year overall survival rate has improved over the years and is currently more than 80% for many types of cancer, thanks to advances in chemotherapy. Unfortunately, chemotherapy drugs have adverse effects such as peripheral neuropathy (so- called chemotherapy-induced peripheral neuropathy, CIPN). CIPN is a debilitating condition that negatively affects the quality of life of affected patients. The drugs used to treat CIPN, such as opioids, antiepileptics, and antidepressants, are often ineffective, and/or have profound adverse effects, such as constipation, sedation, addiction, respiratory depression, and even death. Furthermore, nonpharmacologic treatments such as transcutaneous electrical nerve stimulation (TENS), acupuncture, and yoga have shown mixed results. Importantly, most of the procedures have been tested in adults with CIPN; much less research has been done in adolescent and young adult (AYA) cancer patients. Consequently, the management of CIPN in AYA patients with cancer remains a challenge. Thus, this exploratory R21 proposal addresses the unmet need in treating AYAs with CIPN by introducing a potentially effective noninvasive electrocutaneous nerve stimulation technique called scrambler therapy (ST), which is different from TENS. Given that the clinical presentation of CIPN in AYAs is similar to that of older adults, and with supporting evidence from a recently published small study from Italy, we believe that ST is a promising novel treatment option for patients of all ages with CIPN. Thus, it is worth investigating this novel treatment further. Our central hypothesis is that ST significantly reduces pain and improves neuropathy, physical function, and quality of life (QoL) of AYA cancer patients with CIPN. To test this hypothesis, we propose a prospective, randomized, wait-list controlled pilot study with two specific aims: Specific Aim 1: To evaluate the efficacy and safety of ST for CIPN in AYA cancer patients, and Specific Aim 2: To evaluate the impact of ST on physical functioning and quality of life (QoL) in AYA cancer patients. The overall objective of this proposal is to show that ST may be a valuable alternative to pharmacologic management of CIPN that can effectively improve pain and neuropathy and improve QoL for AYA cancer patients with CIPN. We expect to see significant improvement in pain and other symptom burden of CIPN in AYA patients. Finally, this pilot study is not a mechanistic study. Instead, it will focus on patient-reported outcomes, physical functioning, and QoL to demonstrate effectiveness. As such, pain will be our primary outcome measure, whereas physical performance and QoL will be our secondary outcome measures. The long-term goal is to use ST safely and effectively for all types of intractable neuropathic pain, which if successful, will result in changes in the clinic.

项目摘要/摘要 据估计，在美国，五分之一的孩子患有癌症。幸运的是，5年的总生存率 多年来的改善，目前多种类型的癌症的80％以上，这要归功于进步 化学疗法。不幸的是，化学疗法药物具有不良反应，例如周围神经病（So- 称为化学疗法诱导的周围神经病，CIPN）。 CIPN是一种令人衰弱的状况，负面状态 影响受影响患者的生活质量。用于治疗CIPN的药物，例如阿片类药物，抗癫痫药， 和抗抑郁药通常无效，并且/或具有严重的不利影响，例如便秘， 镇静，成瘾，呼吸抑郁症，甚至死亡。此外，非药物治疗 诸如经牙性电神经刺激（TENS），针灸和瑜伽的结果混合了结果。 重要的是，大多数程序已经在成人CIPN的成年人中进行了测试。进行的研究要少得多 在青少年和年轻人（AYA）癌症患者中。因此，AYA患者的CIPN管理 癌症仍然是一个挑战。因此，此探索性R21提案解决了治疗的未满足需求 通过引入潜在有效的非侵入性电神经刺激的AYA和CIPN 技术称为crambler疗法（ST），与数十个不同。考虑到临床表现 AYAS中的CIPN与老年人相似，并提供了最近出版的小型证据 来自意大利的研究，我们认为ST是所有年龄段CIPN患者的有前途的新型治疗选择。 因此，值得进一步研究这种新颖的治疗方法。我们的中心假设是ST显着 减轻疼痛并改善AYA癌症的神经病，身体机能和生活质量（QOL） CIPN患者。为了检验这一假设，我们提出了一个预期的，随机的，等待名单的控制飞行员 具有两个特定目的的研究：特定目标1：评估CIPN在AYA中的功效和安全性 癌症患者以及特定目的2：评估ST对身体功能和质量的影响 AYA癌症患者的生命（QOL）。该提议的总体目的是表明ST可能是 可以有效改善疼痛和 神经病变并改善CIPN AYA癌症患者的QOL。我们希望看到明显的改善 AYA患者CIPN的疼痛和其他症状负担。最后，这项试验研究不是一项机械研究。 取而代之的是，它将集中于患者报告的结果，身体功能和QOL，以证明有效性。 因此，疼痛将是我们的主要结局措施，而身体表现和质量是我们的 次要结果度量。长期目标是安全有效地用于所有类型的 顽固的神经性疼痛，如果成功的话，将导致诊所的变化。