Fatigue Clinical Trial
Official title:
Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy
NCT number | NCT02758756 |
Other study ID # | UCCS15115 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2016 |
Est. completion date | May 2019 |
Verified date | July 2019 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | May 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Wilmot Cancer Institute | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The revised Brief Fatigue Inventory (BFI) | The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. | The primary outcome measure for this study is fatigue assessed on Friday during study week 6 by the BFI. |
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