Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- The revised Brief Fatigue Inventory (BFI)
研究概览
简要总结
The proposed study will assess whether either massage or an Integrative Medicine practice called Reiki can alleviate fatigue in subjects receiving hormonal treatments. Reiki is classified by the National Center for Complementary and Integrative Health as a biofield/touch therapy, and Reiki practitioners believe that their gentle therapy promotes healing and well-being by unblocking and balancing energy flow and re-establishing homeostasis within the human energy field. The study is a three-arm randomized clinical trial in 99 breast and prostate cancer patients who are undergoing hormonal therapy (i.e., androgen deprivation therapy (ADT) for males or an aromatase inhibitor (AI) for females) and currently experiencing fatigue. Subjects will be studied during ten weeks of hormonal therapy with two weeks of baseline assessments followed by a four-week intervention, and a four-week post-intervention period. Arm 1: Subjects will receive two Swedish-style massages. Arm 2: Lower-dose Reiki intervention - Subjects will receive two Reiki treatments. Arm 3: Higher-dose Reiki intervention - Subjects will receive four Reiki treatments.
详细描述
5.1 This will be a randomized three-arm clinical trial pilot study of an intervention examining the efficacy of either massage or Reiki in reducing fatigue associated with hormonal treatment and to determine if four Reiki treatments are more effective than two in controlling fatigue. Subjects will be studied during ten weeks of hormonal therapy with two weeks of baseline assessments followed by a four-week intervention, and a four-week post-intervention period.
5.1.1 All ancillary treatments for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.
5.1.2 The current protocol is for a pilot study designed to gather preliminary efficacy and feasibility data for the development of a planned RO1 submission. Our intention is to gather preliminary data to generate effect size estimates for power calculations for an anticipated RO1 application. We will also use this preliminary data to help us determine whether or not we should drop or modify one or more of the current study arms when designing the planned RO1 study.
5.1.3 It is preferred that the study be completed in a time-span of ten calendar weeks, however if the subject or practitioner is unable to attend an appointment during a scheduled week, that week will not count as a study week, and it will be designated a skipped week. Only two skipped weeks will be allowed, so the maximum length of the study will be twelve calendar weeks. Subjects will not complete questionnaires during skipped weeks, and skipped weeks may not be consecutive.
5.2 Consent Process and Assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a breast cancer patient receiving an aromatase inhibitor (AI) and not be scheduled to have a change in treatment during the next 10 weeks or have prostate cancer and be on a stable dose of ADT for at least 8 weeks and not be scheduled to have a change in treatment during the next 10 weeks.
- •Be at least two months out from the conclusion of any prior surgery, chemotherapy, radium 223 therapy, abiraterone, enzalutamide, Sipuleucel-T, or radiation therapy.
- •Have a response of 4 or greater on a question assessing fatigue at its worst during the past week that is assessed on an 11-point scale anchored by "0" = no fatigue and "10" = worst possible fatigue.
- •Be able to read English (since the assessment materials will be in a printed format).
排除标准
- •Be scheduled to receive surgery, chemotherapy, radium 223 therapy, abiraterone, enzalutamide, Sipuleucel-T, or radiation therapy during the next 10 weeks.
- •Be taking erythropoietin or darbepoetin for anemia.
- •Have received Therapeutic Touch, Reiki, Polarity Therapy, or professional massage therapy during the prior four weeks.
- •Have a bleeding disorder, blood clot, previous neck/back injury, or other medical condition that would, in the estimation of their physician (or their designee), preclude having massage therapy.
结局指标
主要结局
The revised Brief Fatigue Inventory (BFI)
时间窗: The primary outcome measure for this study is fatigue assessed on Friday during study week 6 by the BFI.
The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity.
次要结局
未报告次要终点
研究者
Luke Peppone
Assistant Professor
University of Rochester