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.

项目概要/摘要 据估计，美国有五分之一的儿童患有癌症。幸运的是，5年总体生存率 多年来已经有所改善，目前多种癌症的治愈率已超过 80%，这要归功于 化疗。不幸的是，化疗药物有副作用，例如周围神经病变（因此 称为化疗引起的周围神经病变（CIPN）。 CIPN 是一种使人衰弱的疾病，会对 影响受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，通常无效，和/或具有严重的副作用，例如便秘， 镇静、成瘾、呼吸抑制，甚至死亡。此外，非药物治疗 经皮神经电刺激（TENS）、针灸和瑜伽等疗法的效果好坏参半。 重要的是，大多数程序已经在患有 CIPN 的成人中进行了测试；所做的研究要少得多 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，这一探索性 R21 提案解决了治疗中未满足的需求 AYA 与 CIPN 引入潜在有效的无创皮神经刺激 一种称为扰频疗法（ST）的技术，与 TENS 不同。鉴于临床表现 AYA 中的 CIPN 与老年人相似，并且有最近发表的小型研究的支持证据 来自意大利的研究表明，我们相信 ST 对于所有年龄段的 CIPN 患者来说都是一种有前景的新型治疗选择。 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 AYA 癌症的疼痛并改善神经病变、身体功能和生活质量 (QoL) CIPN 患者。为了检验这个假设，我们提出了一个前瞻性、随机、等待名单控制的试点 研究有两个具体目标： 具体目标 1：评估 ST 对 AYA CIPN 的疗效和安全性 癌症患者，具体目标 2：评估 ST 对身体功能和质量的影响 AYA 癌症患者的生活质量 (QoL)。该提案的总体目标是表明 ST 可能是 CIPN 药物治疗的宝贵替代方案，可以有效改善疼痛和 神经病变并改善患有 CIPN 的 AYA 癌症患者的生活质量。我们期望看到显着改善 AYA 患者 CIPN 的疼痛和其他症状负担。最后，这项试点研究不是机械研究。 相反，它将重点关注患者报告的结果、身体机能和生活质量以证明有效性。 因此，疼痛将是我们的主要结果衡量标准，而身体表现和生活质量将是我们的主要结果衡量标准 次要结果指标。长期目标是安全有效地将 ST 用于所有类型的 顽固性神经性疼痛，如果成功，将导致临床发生变化。