MedTrace Logo

Pilot Study on Energy Therapy or Massage to Reduce Fatigue

NCT02758756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2019-07-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Massage

Treatments will be on a massage table and last up to 75 minutes. We do not specify what will occur during the massage treatments. Instead we will follow the model of relying on the professional expertise of the therapist in combination with input from the client to determine what should happen in the session. We specify that energy healing techniques not be used, because that is our research comparison condition. We also specify that conversation between the massage therapist and the patient be kept to the minimum necessary to effectively provide the treatment. This is not meant to be talk therapy.

OTHER

Reiki

Reiki treatments will be provided by Reiki Masters on a massage table and last up to 75 minutes. We will not specify what will occur during the Reiki treatments. Instead we will follow the model of relying on the professional expertise of the therapist in combination with input from the client to determine what should happen in the session. That being said, we will ask that two specific things be kept to a minimum. The first is that we ask that Swedish massage techniques not be used, because that is our research comparison condition. The second is that conversation between the massage therapist and the patient be kept to the minimum necessary to effectively provide the treatment. This is not meant to be talk therapy.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Luke Peppone, Ph.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-20
Primary Completion
2019-04-30
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758756 on ClinicalTrials.gov