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: 7732849
• 负责人: Patrick J Mansky
• 金额: $ 19.2万
• 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/7732849
• 关键词: Acupuncture procedure; Acute; Adrenal Cortex Hormones; Adverse effects; Affect; Age; Annual Reports; Anterior; Antiemetics; Biological Markers; Blinded; Childhood Solid Neoplasm; Clinical Management; Diagnosis; Dose; Electroacupuncture; Endocrine; Enrollment; Ewings sarcoma; Female; Flaccid Muscle Tone; Germ cell tumor; Growth; Hodgkin Disease; Hour; Immune system; Immunologics; Infection; Left; Metabolic; Muscle; Nausea; Nausea and Vomiting; Needles; Neuroblastoma; Pain; Participant; Patients; Presbyterian Church; Quality of life; Randomized; Recurrence; Reporting; Research Personnel; Risk; Site; Solid Neoplasm; Stress; Study Subject; Therapeutic; Treatment Protocols; United States National Institutes of Health; Upper Extremity; Upper Limit of Normal; Vomiting; Weight Gain; Withdrawal; Wrist; chemotherapy; day; design; experience; improved; male; 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. 16 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. Four study participants were enrolled on-study since the last annual report; however, none of them completed the study period. One patient, a 12 yo female with Hodgkin lymphoma, was enrolled at Columbia Presbyterian but chose to withdraw from the study on day 2 after experiencing grade 1 pain at the acupuncture insertion site in the right wrist. This resolved within 24 hours after cessation of acupuncture. One patient, a 35 yo male with MPNST/NF1, was enrolled at the NIH but the acupuncturist was unable to administer acupuncture due to flaccidity in the patients upper extremities. Two additional patients were enrolled at Childrens Seattle but were withdrawn from the study by investigators prior to treatment; one was determined to be ineligible due to PT/PTT > upper limit of normal and one was unable to be treated due to unavailability of acupuncturists.

据报道，针刺和电针治疗腕部 P6 点和胫骨前肌 St 36 点可有效减少化疗后急性（24 小时内）发生的恶心和呕吐。尽管急性化疗引起的恶心和呕吐也可以通过现代药物止吐方案有效治疗，但化疗后迟发性恶心（超过 24 小时至 5 天）仍然是临床管理的挑战。诊断为儿童实体瘤的患者可以使用包括高度致吐多药化疗在内的综合方法成功治疗。迟发性恶心通常通过反复服用高剂量皮质类固醇来控制，但治疗效果不佳，并且经常出现不良副作用，例如体重增加、生长迟缓和感染风险增加。复发性或迟发性恶心除了对生活质量 (QOL) 产生负面影响外，还可能对受影响的患者造成压力状态，导致不良的内分泌、代谢和免疫后遗症。针灸治疗急性恶心和呕吐的作用机制尚未阐明。我们发起了一项研究，以确定电针是否能有效治疗小儿实体瘤患者化疗引起的迟发性恶心和呕吐，从而改善这些症状的管理并提高生活质量。我们还旨在确定针灸是否可以减轻这些接受化疗的患者的应激状态，从而扭转其对神经内分泌和免疫系统的负面影响。我们将采用随机、盲法对照、假针刺设计，对总共 52 名年龄 5-35 岁、未接受过化疗的儿科实体瘤患者进行研究，这些患者将在第一次化疗期间接受为期 7 天的电针治疗。周期，然后是一个观察周期的非针灸化疗。迄今为止已入组 16 名研究对象：尤文氏肉瘤（6 名）、骨肉瘤（2 名）、滑膜肉瘤、生殖细胞肿瘤、神经母细胞瘤和其他肉瘤（各 1 名）。 12 人中有 9 人完成了研究； 2 名受试者在第 1 周期期间退出研究（诊断改变 1，自愿退出 1），1 名受试者在第 1 周期后自愿退出研究。 自上次年度报告以来，已有四名研究参与者参加了研究；然而，他们都没有完成学习期。一名患有霍奇金淋巴瘤的 12 岁女性患者曾在哥伦比亚长老会医院入组，但在右手腕针灸插入部位出现 1 级疼痛后，选择在第二天退出研究。 停止针灸后 24 小时内即可解决。 一名患有 MPNST/NF1 的 35 岁男性患者在 NIH 入组，但由于患者上肢无力，针灸师无法进行针灸治疗。另外两名患者被纳入西雅图儿童医院，但在治疗前被研究人员退出研究；一名因 PT/PTT > 正常上限而被确定为不合格，一名因针灸师不在而无法接受治疗。