Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

描述（申请人提供）：该提案直接解决了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）发布的PA-08-121癌症和免疫疾病症状相互作用的目标。征求研究“设计和测试针对相互作用或聚集的症状的干预措施，这些症状被假设会导致有益的患者结果。“这项生物行为随机临床试验（RCT）的总体目标是检查一种创新的非药物症状管理模式，颅微电流电刺激（CES）在辅助化疗治疗期间改善早期乳腺癌（BC）女性（N=150）的心理神经症状（抑郁，焦虑，疲劳，疼痛和睡眠障碍）的效果。CES是一种非侵入性，便携式和易于标准化的模式，已被FDA批准为抑郁情绪，焦虑，疼痛和失眠的无药物治疗。拟议的研究建立在一项由NCI资助的试验性可行性研究（R21 CA 106149，里昂，PI）的基础上，该研究是在接受乳腺癌化疗的女性中进行的。我们的初步研究结果支持在早期乳腺癌妇女辅助化疗阶段使用CES的安全性和可行性。基于初步研究的结果，本RCT的主要目的是比较CES与假CES随时间推移对接受辅助化疗的早期乳腺癌女性抑郁、焦虑、疲劳、疼痛和睡眠障碍症状的影响。探索性目的是（1）探索选定的炎症标志物之间的关系（2）检查抑郁、焦虑、疲劳、睡眠障碍和疼痛症状是否形成集群;（3）研究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、双盲临床试验实现。将使用纵向重复测量模型比较辅助化疗期间CES干预与假对照组的效果。这些发现可能对肿瘤学中多种常见的令人痛苦的症状的症状管理具有有价值的意义。此外，拟议的研究将增加对症状模式随时间推移的科学理解，症状与炎症标志物的关系，并为探索这些症状的聚类提供数据。公共卫生相关性：这项研究的结果有可能减少接受乳腺癌化疗的妇女的癌症化疗的不适，从而提高生活质量。这项研究的结果也可能有助于更清楚地确定常见的，令人痛苦的症状的生物学原因。

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. PUBLIC HEALTH RELEVANCE: The results of this study have the potential to reduce the discomforts of cancer chemotherapy in women receiving chemotherapy for breast cancer, thereby enhancing quality of life. Results from this study may also help to identify more clearly the biological causes for common, distressing symptoms.