Cranial Stimulation for Chemo Symptoms in Breast Cancer

描述（由申请人提供）：乳腺癌是美国女性癌症死亡的第二大原因。虽然现在推荐用于局部和转移性乳腺癌，但化疗通常会导致令人痛苦的症状，如疲劳、抑郁、焦虑、疼痛和睡眠障碍。由于改善这些症状的传统方式的局限性，因此非常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）已经在不同的临床人群中证明了缓解抑郁和焦虑症状、疲劳、睡眠障碍和疼痛的安全性和有效性。这项创新的试点研究提出了一项为期10周的CES试验，以减轻接受乳腺癌辅助化疗的妇女常见的痛苦症状。我们建议进行一项随机双盲研究，比较与假手术组和常规治疗组（对照组）相比，CES对症状（抑郁和焦虑、疲劳、疼痛、睡眠障碍）和生物标志物（NE、E、血清素、皮质醇、IL-1、IL-6和TNF-a）的影响。除了通过综合语音技术（IVR）收集的每周症状测量外，还将通过收集与症状报告并行的生物测量来检查这些症状的潜在生理机制。三组设计（活动CES，假CES和常规护理）将为检查安慰剂效应（如果有的话）提供数据。由于缺失数据是临床试验中常见的问题，我们将试点测试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效应，并将促进新研究者进入癌症以及补充和替代模式领域。

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.