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: 10363448
• 负责人: Salahadin Abdi
• 金额: $ 22.72万
• 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/10363448
• 关键词: Acupuncture Therapy; Address; Adolescent; Adolescent and Young Adult; Adult; Adverse effects; Affect; Age; Analgesics; Antidepressive Agents; Antiepileptic Agents; Blinded; Brief Pain Inventory; Cancer Patient; 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; Patient Outcomes Assessments; Patients; Peripheral Nervous System; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Physical Function; Physical Performance; 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; base; 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.

项目总结/摘要 据估计，美国每五个儿童中就有一个患有癌症。幸运的是，5年总生存率 多年来已经改善，目前对许多类型的癌症超过80%，这要归功于 化疗不幸的是，化疗药物有副作用，如周围神经病变（所以- 称为化疗诱导的周围神经病变（CIPN）。CIPN是一种使人衰弱的疾病， 影响患者的生活质量。用于治疗CIPN的药物，如阿片类药物，抗癫痫药， 和抗抑郁药，通常是无效的，和/或具有严重的副作用，例如便秘， 镇静剂成瘾呼吸抑制甚至死亡此外，非药物治疗 例如经皮电神经刺激（TENS）、针灸和瑜伽已经显示出混合的结果。 重要的是，大多数手术都是在患有CIPN的成年人中进行测试的;很少有研究已经完成 青少年和年轻成人（AYA）癌症患者。因此，AYA患者的CIPN管理 癌症仍然是一个挑战。因此，该探索性R21提案解决了治疗中未满足的需求， 通过引入潜在有效的非侵入性经皮神经电刺激，使用CIPN进行AYA 技术称为扰码治疗（ST），这是从TENS不同。鉴于临床表现， AYAs的CIPN与老年人相似，最近发表的一项小型研究提供了支持证据。 根据来自意大利的研究，我们认为ST是所有年龄CIPN患者有希望的新治疗选择。 因此，值得进一步研究这种新的治疗方法。我们的中心假设是ST显著 减轻疼痛并改善AYA癌症的神经病变、身体功能和生活质量（QoL） CIPN患者为了验证这一假设，我们提出了一个前瞻性的，随机的，等待名单控制的试点 研究有两个特定目的：特定目的1：评价ST治疗AYA患者CIPN的疗效和安全性 具体目标2：评价ST对身体功能和质量的影响 AYA癌症患者的生活质量（QoL）。本提案的总体目标是表明ST可能是一个 有价值的替代药物管理CIPN，可以有效地改善疼痛， 神经病变和改善生活质量的AYA癌症患者与CIPN。我们预计， AYA患者CIPN的疼痛和其他症状负担。最后，这项试点研究不是一项机械研究。 相反，它将重点关注患者报告的结局、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指标，而体能和生活质量将是我们的主要结局指标。 次要结局指标。长期目标是将ST安全有效地用于所有类型的 顽固性神经性疼痛，如果成功，将导致临床的变化。