Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

描述(由申请人提供)：这项建议直接涉及PA-08-121癌症和免疫疾病症状相互作用的目标，该目标由国家护理研究所(NINR)、国家癌症研究所(NCI)、国家补充和替代医学中心(NCCAM)、国家老龄研究所(NIA)、国家卫生研究院(NIH)发布，旨在征集研究，以“设计和测试针对相互作用或聚集的症状的干预措施，假设这些症状将导致有益的患者结果。”这项生物行为随机临床试验(RCT)的总体目标是检验一种创新的非药物症状管理方式--颅脑微电流电刺激(CES)在辅助化疗治疗期内改善早期乳腺癌(BC)妇女(N=150)的精神神经症状(抑郁、焦虑、疲劳、疼痛和睡眠障碍)的效果。CES是一种非侵入性、便携、易于标准化的治疗方法，已被FDA批准为治疗抑郁、焦虑、疼痛和失眠的非药物治疗方法。这项拟议的研究建立在NCI资助的CES在接受乳腺癌化疗的妇女中的可行性研究(R21 CA106149，里昂，PI)的基础上。我们的初步研究结果支持在早期乳腺癌患者的辅助化疗阶段使用CES的安全性和可行性。在试点研究结果的基础上，这项随机对照试验的主要目的是比较CES和假CES随着时间的推移对接受辅助化疗的早期乳腺癌患者的抑郁、焦虑、疲劳、疼痛和睡眠障碍症状的影响。研究的目的是(1)探讨选定的炎症标志物(肿瘤坏死因子α[TNF-1]、白介素6[IL-6]、白介素1-2[IL1-2]和C反应蛋白[CRP])、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一簇；以及(3)检查CES对生活质量的影响。具体目标将通过前瞻性、随机化、假对照、双盲临床试验来实现。将使用纵向重复测量模型来比较CES干预和假对照组在辅助化疗期间的效果。这些发现可能对肿瘤学中多种常见、令人痛苦的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的模式、症状与炎症标志物的关系的科学理解，并为探索这些症状的聚集提供数据。

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.