Pilot Study on Energy Therapy or Massage to Reduce Fatigue
Completed · Not applicable
Conditions studied: Fatigue
In brief
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.
Key facts
- Study ID
- NCT02758756
- Run by
- University of Rochester
- People needed
- 87
- Starts
- 2016-06-20
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2019-07-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University of Rochester Wilmot Cancer Institute — Rochester, New York, United States
Full record on ClinicalTrials.gov
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