Polarity Therapy for Cancer-Related Fatigue

描述（由申请人提供）：癌症相关性疲乏（CRF）是癌症及其治疗最常报告的副作用。我们的数据和文献表明，60 - 96%的患者在治疗过程中的某个时间点经历CRF。除了对健康相关生活质量（HRQL）和日常生活活动产生深远影响外，CRF还可促进睡眠障碍增加、工作相关活动困难、肌肉无力和休闲活动减少。目前，没有现存的数据支持任何特定治疗CRF的有效性。我们的研究小组收集的初步数据表明，极性疗法（PT）是一种有效的非侵入性干预措施，以减轻CRF。15名接受标准治疗、一种PT治疗或两种PT治疗的接受乳腺癌放射治疗的CRF女性报告，与接受标准治疗的女性相比，单次PT治疗后的疲劳程度在统计学上显著降低（p <0.05）。在接受PT治疗的10例患者中有8例患者观察到PT治疗后疲劳改善，而接受标准治疗的5例患者中仅1例报告疲劳改善。目前的申请是一项试点研究，该研究将通过提供关于PT在接受结肠直肠癌化疗患者中降低CRF、改善HRQL和改善睡眠质量（QOS）的疗效的初步数据来扩展这些先前的研究结果。此外，该试点研究旨在完善程序和方法，提供样本量估计，并帮助对计划的R 01提交进行中介和调节分析的先验设计。本研究将采用3组随机临床试验设计，纳入60例接受结直肠癌辅助化疗的CRF患者。第1组：患者（非干预对照组）将接受标准临床护理。第2组：患者（活性对照组）将接受标准临床护理加2次颈部、肩部和手部按摩治疗。第3组：患者将接受标准临床治疗加2次PT治疗。患者将接受为期21天的研究，包括每周3次化疗输注。将在基线和两次干预后评估时评估疲劳、HRQL和QOS。除了睡眠/疲劳日记外，在整个21天研究期间将使用体动记录仪，以提供睡眠和疲劳的客观测量。预期结果可在CRF的研究和治疗中具有临床、方法学和理论应用。

DESCRIPTION (provided by applicant): Cancer-related fatigue (CRF) is the most frequently reported side effect of cancer and its treatment. Our data and the literature suggest that 60 - 96% of patients experience CRF at some point during their course of treatment. In addition to its profound effect on health-related quality of life (HRQL) and activities of daily living, CRF can promote increased sleep disturbance, difficulties with work-related activities, muscle weakness, and reduction in leisure activity. At present, no extant data support the effectiveness of any specific treatment for CRF. Preliminary data gathered by our research team suggests that Polarity Therapy (PT) is an efficacious non-invasive intervention for alleviating CRF. Fifteen women with CRF receiving radiation therapy for breast cancer who received either standard care, one PT treatment or two PT treatments reported a statistically significant (p < .05) reduction in fatigue after a single PT treatment compared to women receiving standard care. The improvement in fatigue observed with PT was found in 8 of 10 patients receiving PT, with only 1 of 5 patients receiving standard care reporting improvement in fatigue. The current application is for a pilot study that will extend these previous findings by providing preliminary data on the efficacy of PT for reducing CRF, improving HRQL, and improving quality of sleep (QOS) in patients receiving chemotherapy for colorectal cancer. Additionally, this pilot study is designed to refine procedures and methods, provide a sample-size estimate, and aid in the a priori design of mediator and moderator analyses for a planned R01 submission. The current study will utilize a 3-Arm randomized clinical trial design with 60 patients experiencing CRF undergoing adjuvant chemotherapy for colorectal cancer. Arm 1: patients (non-intervention control group) will receive standard clinical care. Arm 2: patients (active control group) will receive standard clinical care plus 2 neck, shoulder and hand massage treatments. Arm 3: patients will receive standard clinical care plus 2 PT treatments. Patients will be studied for a 21-day period encompassing three weekly chemotherapy infusions. Fatigue, HRQL and QOS will be assessed at baseline and at two post-intervention assessments. In addition to a sleep/fatigue diary, actigraphy will be used during the entire 21-day study period to provide objective measures of sleep and fatigue. Anticipated results could have clinical, methodological, and theoretical application in the study and treatment of CRF.