Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

描述（由申请人提供）：本提案直接针对由美国国家护理研究所（NINR）、美国国家癌症研究所（NCI）、美国国家补充和替代医学中心（NCCAM）、美国国家老龄化研究所（NIA）、美国国家卫生研究院（NIH）、美国国立卫生研究院（NIH）、美国国立卫生研究院（NIH）、美国国立卫生研究院（NIH）、美国国立卫生研究院（NIH）和美国国立卫生研究院（NIH）发布的PA-08-121癌症和免疫疾病症状相互作用的目标。要求研究“设计和测试针对相互作用或聚集性症状的干预措施，假设这些症状会导致有益的患者结果。”这项生物行为随机临床试验（RCT）的总体目标是研究一种创新的非药物症状管理方式，颅微电流电刺激（CES）在辅助化疗期间改善早期乳腺癌（BC）妇女（N=150）的精神神经系统症状（抑郁、焦虑、疲劳、疼痛和睡眠障碍）的效果。CES是一种无创、便携、易于标准化的治疗方式，已被FDA批准为一种治疗抑郁情绪、焦虑、疼痛和失眠的无药治疗方法。拟议的研究建立在一项nci资助的试点可行性研究（R21 CA106149, Lyon， PI）的基础上，该研究对接受乳腺癌化疗的女性进行了CES。我们的试点研究结果支持在早期乳腺癌女性辅助化疗阶段使用CES的安全性和可行性。在初步研究的基础上，本随机对照试验的主要目的是比较ce与假ce随时间推移对接受辅助化疗的早期乳腺癌妇女抑郁、焦虑、疲劳、疼痛和睡眠障碍症状的影响。探索目的是：(1)探讨选定的炎症标志物（肿瘤坏死因子α [TNF-1]、白细胞介素-6 [IL-6]、白细胞介素-1 -2 [il -1 -2]、c反应蛋白[CRP]）与症状和生活质量之间的关系；(2)检查抑郁、焦虑、疲劳、睡眠障碍和疼痛的症状是否形成集群；(3)研究消费消费对生活质量的影响。具体目标将通过前瞻性、随机、假对照、双盲临床试验来实现。在辅助化疗期间，将使用纵向重复测量模型来比较CES干预与假对照组的效果。这些发现可能对肿瘤中多种常见的痛苦症状的症状管理具有重要意义。此外，拟议的研究将增加对症状随时间变化模式的科学理解，症状与炎症标志物的关系，并为探索这些症状的聚集性提供数据。

DESCRIPTION (provided by applicant): This proposal directly addresses the goal of PA-08-121 Symptom Interactions in Cancer and Immune Disorders issued by the National Institute of Nursing Research (NINR), National Cancer Institute (NCI), National Center on Complementary and Alternative Medicine (NCCAM), and National Institute on Aging (NIA), National Institutes of Health (NIH), soliciting research to "design and test interventions targeted to interacting or clustered symptoms that are hypothesized to lead to beneficial patient outcomes." The overall goal of this biobehavioral, randomized clinical trial (RCT) is to examine the effects of an innovative, nonpharmacological symptom management modality, cranial microcurrent electrical stimulation (CES,) for ameliorating psychoneurologic symptoms (depression, anxiety, fatigue, pain and sleep disturbances) in women (N=150) with early-stage breast cancer (BC) over the adjuvant chemotherapy treatment period. CES is a non-invasive, portable, and easily standardized modality that been approved by the FDA as a drug-free treatment for depressed mood, anxiety, pain and insomnia. The proposed study builds on a NCI-funded pilot, feasibility study (R21 CA106149, Lyon, PI) of CES in women receiving chemotherapy for breast cancer. Results from our pilot study support the safety and feasibility of the use of CES during the adjuvant chemotherapy phase in women with early-stage breast cancer. Building on the findings of the pilot study, the primary aim of this RCT is to compare the effects of CES to sham CES over time on symptoms of depression, anxiety, fatigue, pain and sleep disturbances in women with early-stage breast cancer receiving adjuvant chemotherapy. Exploratory aims are to (1) explore the relationships among selected markers of inflammation (tumor necrosis factor alpha [TNF-1], interleukin-6 [IL-6], interleukin-IL1-2 [IL1-2], and C-reactive protein [CRP]), symptoms and QOL; (2) examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances and pain form a cluster; and (3) examine the effects of CES on QOL. The specific aims will be accomplished using a prospective, randomized, sham-controlled, double-blinded clinical trial. A longitudinal repeated measures model will be used to compare the effects of the CES intervention to the sham control group over the adjuvant chemotherapy period. These findings could have valuable implications for symptom management of multiple common, distressing symptoms in oncology. Further, the proposed study will add to scientific understanding of the pattern of symptoms over time, the relationships of symptoms with markers of inflammation, and provide data for exploring the clustering of these symptoms.