Electroacupuncture Treatment For Delayed Chemotherapy-induced Nausea And Emesis

电针治疗延迟化疗引起的恶心和呕吐

• 批准号: 7592495
• 负责人: Patrick J Mansky
• 金额: $ 97.4万
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7592495
• 关键词: Acupuncture procedure; Acute; Adrenal Cortex Hormones; Adverse effects; Affect; Age; Anterior; Antiemetics; Biological Markers; Blinded; Childhood Solid Neoplasm; Clinical Management; Diagnosis; Dose; Electroacupuncture; Endocrine; Enrollment; Ewings sarcoma; Germ cell tumor; Growth; Hour; Immune system; Immunologics; Infection; Left; Metabolic; Muscle; Nausea; Nausea and Vomiting; Needles; Neuroblastoma; Patients; Quality of life; Randomized; Recurrence; Reporting; Risk; Solid Neoplasm; Stress; Study Subject; Therapeutic; Treatment Protocols; Vomiting; Weight Gain; Withdrawal; Wrist; chemotherapy; day; design; improved; osteosarcoma; sarcoma; stressor; symptom management; synovial sarcoma; treatment duration

Acupuncture and electroacupuncture at the P6 point in the wrist and the St 36 point in the anterior tibialis muscle have been been reported to be effective in reducing nausea and emesis occurring acutely (less than 24 hours) after chemotherapy. Although acute chemotherapy-induced nausea and emesis can be also be effectively treated with contemporary pharmacologic anti-emetic regimens, delayed nausea (more than 24 hours to 5 days) after chemotherapy continues to be a clinical management challenge. Patients diagnosed with pediatric solid tumors can be successfully treated using a comprehensive approach that includes highly emetogenic multi-agent chemotherapy. Delayed nausea is often managed by recurrent administration of high dose corticosteroids, with suboptimal therapeutic benefit and frequent undesirable side effects, such as weight gain, growth retardation and increased risk for infections. Recurrent or delayed nausea, in addition to its negative effect on Quality of Life (QOL), may constitute a state of stress for the affected patient, contributing to adverse endocrine, metabolic and immunologic sequelae. Mechanisms of activity of acupuncture in the treatment of acute nausea and emesis have not been clarified. We have initiated a study to determine whether electroacupuncture is effective in the treatment of chemotherapy-induced delayed nausea and emesis in patients with pediatric solid tumors, resulting in improved management of these symptoms and enhanced QOL. We also aim to identify whether acupuncture reduces the stressor state of these chemotherapy-treated patients, reversing its negative effects on the neuro-endocrine and immune systems. Using a randomized, blinded design with control, sham needling, we shall study a total of 52 chemotherapy-naive patients with pediatric solid tumors, age 5-35 years, who will be enrolled for one electroacupuncture treatment period of 7 days during the first chemotherapy cycle, followed by one observation cycle of chemotherapy without acupuncture. 12 study subjects have been enrolled to date: Ewings sarcoma (6), osteosarcoma (2), synovial sarcoma, germ cell tumor, neuroblastoma and other sarcoma (one each respectively). Nine of the 12 completed the study; 2 subjects left the study during cycle 1 (change in diagnosis 1, voluntary withdrawal 1), one subject voluntarily withdrew from the study after cycle 1.

据报道，腕部肌肉的P6点的针灸和电针刺据报道，胫骨前肌的ST 36点有效减少恶心，化学疗法后急性（小于24小时）发生呕吐。尽管急性化学疗法引起的恶心和呕吐也可以通过当代药理抗雌激素方案有效治疗，但化学疗法后的恶心延迟（超过24小时至5天）继续是临床管理挑战。可以使用综合方法成功治疗被诊断为小儿实体瘤的患者，该方法包括高度突出的多药化学疗法。延迟的恶心通常通过反复施用高剂量皮质类固醇，具有次优的治疗益处和频繁的不良副作用，例如体重增加，增长迟缓和感染风险增加。除了对生活质量的负面影响（QOL）外，复发性或延迟的恶心还可能构成受影响患者的压力状态，从而导致内分泌，代谢和免疫后遗症。尚未澄清针灸治疗中针灸活性的机制。我们已经开始了一项研究，以确定电针作是否有效治疗儿科实体瘤患者的化学疗法引起的延迟恶心和屈服，从而改善了这些症状的治疗和增强的QOL。我们还旨在确定针灸是否减少了这些化学疗法治疗的患者的压力源状态，从而扭转了其对神经内分泌和免疫系统的负面影响。使用带有对照，假针的随机盲设计，我们将研究52例儿童固体瘤患者，年龄为5-35岁，他们将在第一次化学疗法期间招募7天的7天电针治疗期周期，然后是一个无针灸的化学疗法观察周期。迄今为止，已有12个研究对象已经入学：Ewings肉瘤（6），骨肉瘤（2），滑膜肉瘤，生殖细胞肿瘤，神经母细胞瘤和其他肉瘤（分别分别为一个）。这12个完成了这项研究； 2个受试者在周期1（诊断1的变化，自愿戒断1的变化）中离开了研究，一名受试者自愿退出了第1周期之后的研究。