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.

项目总结/文摘