Cranial Stimulation for Chemo Symptoms in Breast Cancer

描述(申请人提供)：乳腺癌是美国女性癌症死亡的第二大原因。虽然现在建议对局部和转移性乳腺癌进行化疗，但化疗往往会导致疲劳、抑郁、焦虑、疼痛和睡眠障碍等令人痛苦的症状。由于改善这些症状的传统方法的局限性，迫切需要进一步开发和测试用于减轻症状的补充疗法。颅电刺激(CES)在缓解不同临床人群的抑郁和焦虑症状、疲劳、睡眠障碍和疼痛方面已经证明是安全和有效的。这项创新的试点研究建议进行为期10周的CES试验，以减少接受乳腺癌辅助化疗的妇女的常见痛苦症状。我们提出了一项随机、双盲研究，比较CES与假手术组和常规治疗(对照组)对症状(抑郁和焦虑、疲劳、疼痛、睡眠障碍)和生物标记物(NE、E、5-羟色胺、皮质醇、IL-1、IL-6和TNF-α)的影响。除了通过集成语音技术(IVR)收集每周的症状测量外，还将通过在收集症状报告的同时收集生物测量来检查这些症状的潜在生理机制。三组设计(主动CES、假CES和常规护理)将为检查安慰剂效应提供数据(如果有)。由于数据缺失是临床试验中的常见问题，我们将试行使用交互式语音应答(IVR)技术来收集和管理数据。这项研究将为更大规模的随机对照试验提供基础，以检验CES对接受乳腺癌辅助化疗的妇女的疗效和生理影响，并将促进一名新的研究人员进入癌症和补充和替代疗法领域。

DESCRIPTION (provided by applicant): Breast cancer is the second leading cause of cancer death in women in the United States. While now recommended for both localized and metastatic breast cancer, chemotherapy often results in distressing symptoms of fatigue, depression, anxiety, pain and sleep disturbances. Because of the limitations of conventional modalities for ameliorating these symptoms, there is a great need for the further development and testing of complementary therapies for symptom reduction. Cranial electrostimulation (CES) has demonstrated safety and efficacy for reliving depressive and anxiety symptoms, fatigue, sleep disturbances and pain in diverse clinical populations. This innovative pilot study proposes a 10-week trial of CES for reducing common, distressing symptoms in women receiving adjuvant chemotherapy for breast cancer. We propose a randomized, double-blinded study of the effects of CES compared to a sham group and treatment as usual (control group), on symptoms (depression and anxiety, fatigue, pain, sleep disturbances,) and biologic markers (NE, E, Serotonin, cortisol, IL-1, IL-6, and TNF-a). In addition to weekly symptom measures collected via Integrative Voice Technology (IVR), underlying physiologic mechanisms of these symptoms will be examined by collecting biologic measures in parallel to the symptom reports. The three-group design (active CES, sham CES, and usual care) will provide data for examining the placebo effect, if any. Since missing data is a common problem in clinical trials, we will pilot test the use of Interactive Voice Response (IVR) technology to collect and manage data. This study will provide the foundation for a larger RCT to examine the efficacy and physiologic effects of CES for women receiving adjunctive chemotherapy for breast cancer and will facilitate the entry of a new investigator into the field of cancer and complementary and alternative modalities.