Acupressure for Persistent Cancer Related Fatigue

描述（由申请人提供）：今天有超过200万乳腺癌幸存者。持续性癌症相关疲劳（PCRF）是一种疲劳或疲倦的状态，是乳腺癌（BC）幸存者最常见和最痛苦的症状之一。在确诊后的前5年内，BC幸存者中显著PCRF的发生率从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幸存者在诊断时主观报告的低水平疲劳预示着更长的无复发（风险比[RR] 1.32, 95%置信区间[CI] 1.13-1.54）和总生存期（RR 1.23, 95%CI 1.05-1.44）。因此，减少PCRF可能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医生，费用高昂，对患者造成相当大的负担，或者有不可接受的副作用。指压是一种源自针灸的技术，是中医的一个组成部分。在指压疗法中，通过手、肘或用各种器械对穴位施加物理压力来治疗疾病。初步研究表明，自我穴位按压可以显著降低癌症幸存者高达70%的PCRF。穴位按摩对癌症患者和其他慢性病患者的睡眠质量也有积极的影响。我们已经在PCRF中进行了穴位按压的临床试验。在该试验中，我们观察到两种穴位按压方法的不同效果，放松和刺激穴位按压，两者都能减少PCRF，放松的效果明显更大。自我穴位按摩是一种无毒、廉价的治疗方法，只需要很少的指导。穴位按压也需要很少的努力和时间对病人的一部分，以成功完成。因此，穴位按压似乎是一种有希望的治疗PCRF和相关症状。因此，我们提出了一项单盲、安慰剂对照研究，以检验两种相反的指压治疗与标准治疗相比的具体效果。该研究将在375名BC患者中进行，这些患者在完成癌症治疗至少12个月后，患有中度至重度PCRF，他们将被随机分为三组：(1)放松指压[RA]；刺激指压；或标准护理6周，然后是4周的洗脱期。我们的主要目的是检验6周RA与SA或标准护理对疲劳的影响，评估方法如下：(1)使用简短疲劳量表进行每周自我报告；(2)活动记录仪显示的白天客观体力活动情况；或(3)疲劳模式每天评估4次，使用视觉模拟量表。次要终点包括检查两种穴位按摩疗法或睡眠质量的护理标准，以及在临床环境中实施穴位按摩所需的重要动力学参数；主要是6周治疗期内穴位按压对疲劳和睡眠的作用发生时间，以及4周洗脱期RA和SA的作用持续时间。

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.