Acupressure for Persistent Cancer Related Fatigue

描述(申请人提供)：今天有超过200万的乳腺癌幸存者。持续性癌症相关性疲劳(PCRF)是乳腺癌(BC)幸存者最常见和最痛苦的症状之一，是一种疲惫或疲倦的状态。在确诊的头5年内，BC幸存者显著的PCRF发生率从30%到82%不等。PCRF与生活质量下降、睡眠质量下降和抑郁有关。此外，BC幸存者诊断时疲倦程度低的主观报告预测了更长的无复发(风险比[RR]1.32，95%可信区间[CI]1.13-1.54)和总存活率(RR 1.23，95%可信区间1.05-1.44)。因此，降低PCRF可能会对妇女的生活质量和生存产生积极影响。PCRF的治疗选择很少，这些治疗需要训练有素的从业者，相关费用很高，对患者造成相当大的负担，或者有不可接受的副作用。穴位按摩是一种源于针灸的技术，针灸是中医的一个组成部分。在穴位按摩中，通过手部、肘部或各种设备将物理压力施加到穴位上，以治疗疾病。初步研究表明，在癌症幸存者中，自我穴位按压可以显著降低PCRF高达70%。穴位按压对癌症患者和其他慢性病患者的睡眠质量也有积极影响。我们已经在PCRF中进行了穴位按压的试点临床试验。在那次试验中，我们观察到了两种穴位按压公式的不同效果，放松和刺激穴位按压都降低了PCRF，其中放松的影响明显更大。自我穴位按摩是一种无毒和廉价的治疗方法，只需最少的指导。穴位按压也只需要患者很少的努力和时间就能成功完成。因此，穴位按压似乎是治疗PCRF及其相关症状的一种有前途的治疗方法。因此，我们提出了一项单盲、安慰剂对照研究，以检验两种相反的穴位按压疗法与标准护理相比的具体效果。这项研究将在癌症治疗完成至少12个月后的375名公元前幸存者中进行，他们患有中到重度的PCRF，他们将被随机分为3组：(1)放松穴位按压[RA]；刺激穴位按压[SA]；或标准护理6周，然后是4周的冲洗期。我们的主要目的是检查6周的RA与SA或护理标准相比对疲劳的影响，评估方法是：(1)使用简短的疲劳量表进行每周自我报告；(2)在Actigraph上进行客观的日间体力活动；或(3)使用视觉模拟标尺每天评估4次疲劳模式。次要终点包括检查两种穴位按压方案或对睡眠质量的护理标准，以及在临床环境中实施穴位按压所需的重要动力学参数；主要是在6周治疗期间穴位按压对疲劳和睡眠的影响起效的时间，以及在4周冲洗期内RA和SA的作用持续时间。 公共卫生相关性：目前有200多万乳腺癌幸存者，持续性癌症相关疲劳(PCRF)是乳腺癌(BC)幸存者最常见和最痛苦的症状之一，PCRF是一种疲惫或疲惫的状态。这项研究将检验一种从传统中药中提取的低成本、安全的治疗方法--自我穴位按压，以治疗BC幸存者的疲劳。减少这些女性的疲劳感能够改善她们的生活质量，并有可能延缓或防止BC复发。

DESCRIPTION (provided by applicant): There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5- years of diagnosis. PCRF is associated with decreased quality of life, decreased sleep quality and depression. Also, subjective reports of low levels of fatigue at diagnosis in BC survivors predict longer recurrence-free (risk ratio [RR] 1.32, 95% confidence interval [CI] 1.13-1.54) and overall survival (RR 1.23, 95%CI 1.05-1.44). Consequently, decreasing PCRF could have a positive impact on women's quality of life and on survival. There are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects. Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. We have performed a pilot clinical trial of acupressure in PCRF. In that trial we observed differential effects of two acupressure formulas, relaxation and stimulatory acupressure, both of which reduced PCRF, with relaxation having a significantly greater effect. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. Acupressure also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms. As such, we propose a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. This study would be conducted in 375 BC survivors at least 12 months after completion of cancer treatments, with moderate to severe PCRF, who will be randomized to one of 3 groups: (1) relaxation acupressure [RA]; stimulating acupressure [SA]; or standard of care for 6-weeks followed by a 4-week washout period. Our primary aim is to examine the effect of 6-weeks of RA compared to SA or standard of care on fatigue as assessed by: (1) weekly self-report using the Brief Fatigue Inventory; (2) objective daytime physical activity on actigraph; or (3) fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include the examination of the two acupressure regimes or standard of care on sleep quality, and on important kinetic parameters required for implementation of acupressure in a clinical setting; mainly the time to onset for effects of acupressure on fatigue and sleep during the 6-week treatment period and the duration of effect of RA and SA during the 4-week washout period. PUBLIC HEALTH RELEVANCE: There are over 2 million breast cancer survivors today and persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. This study will examine a low cost and safe treatment derived from Traditional Chinese Medicine, self- administered acupressure, to treat fatigue in BC survivors. Decreasing fatigue in these women has the ability to improve their quality of life and possibly delay or prevent BC recurrence.