Pilot Study on Energy Therapy or Massage to Reduce Fatigue

NCT02758756 | Completed DMC

• 1 other identifier: UCCS15115
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Massage

ACTIVE COMPARATOR

Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart.

Other: Massage

Two Reiki Tx

EXPERIMENTAL

Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart.

Other: Reiki

Four Reiki Tx

EXPERIMENTAL

Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart.

Other: Reiki

Interventions

Massage OTHER

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.

Massage

Reiki OTHER

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.

Also known as: Energy Therapy

Four Reiki Tx; Two Reiki Tx

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Massage; Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Spiritual Therapies

Study Officials

• Luke Peppone, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: June 20, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)