FatigueNCT02758756
Pilot Study on Energy Therapy or Massage to Reduce Fatigue
A study testing Massage and Reiki in people with Fatigue, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Massage and Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Wilmot Cancer Institute
Rochester, New York, 14642
About this study
Official title: Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy
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.
Read the detailed description
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
5.2.1 After providing written informed consent (and receiving a signed copy), the subject will complete an On-Study Data Form providing demographic and clinical data. Questions concerning the subject's experience with both Reiki and massage (and related treatments) and expectations for their efficacy in relieving fatigue are also included. Subjects will also complete a quality of life (QOL) questionnaire and sleep quality (SQ) questionnaire at time of consent.
5.2.2 Subjects will be asked to completed study questionnaires at home. They will have the option of completing questionnaires via the REDCap online survey system (see Section 6.10) or on paper. If they choose to complete paper questionnaires, they will be given a packet of study questionnaires at the time of consent. The questionnaire packet will consist of seven sets of questionnaires. Each set will have the Brief Fatigue Inventory (BFI), the Insomnia Severity Index (ISI), and a Symptom Inventory. In addition, the sixth and seventh sets of questionnaires will also include the Pittsburgh Sleep Quality Inventory (PSQI) to assess SQ, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) to assess QOL, and the Profile of Mood States (POMS). If they choose to complete questionnaires via REDCap, they will be asked to complete the same questionnaires through the online survey system. Subjects electing to use REDCap will also be given one set of paper questionnaires to be used in the event that computer access is not available when needed.
5.2.3 Subjects will be asked to complete one set of questionnaires (either through REDCap or on paper) each Friday night of the 2-week baseline and the 4-week intervention period. They will be asked to complete a final set on Friday of Week 10. A set of questionnaires takes about 10-20 minutes to complete.
5.2.4 Reminder phone calls or emails will be made by study personnel each Friday to assist the subject in remembering to complete the study forms. If they have chosen to complete paper questionnaires, they will also be instructed to return them in the provided stamped, pre-addressed envelope. (Permission will be obtained to leave messages on a subject's voicemail before any messages are left.)
5.3 An optional Heart Rate Variability (HRV) assessment will be done during study weeks 2 and 7 at the PEAK Laboratory at the URMC (see Section 6.7).
5.4 An optional fasting (8-hour) blood draw will be done at the URMC to estimate cytokines (CRP, IL-6, \& TNF-α) during study weeks 2 and 7 (see Section 6.8).
5.5 Treatment Arms:
5.5.1 Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart.
5.5.2 Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart.
5.5.3 Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart.
5.5.4 Scheduling arrangements will be made for the treatments prior to the initiation of the intervention.
5.5.6 Subjects will not be charged for the Reiki or massage treatments.
- Conditions
- Fatigue
- Being tested
- Massage, Reiki
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
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.
ReikiOther
Also called Energy Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Active comparator | Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart. Receives: Other: Massage |
| Two Reiki Tx | Experimental | Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart. Receives: Other: Reiki |
| Four Reiki Tx | Experimental | Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart. Receives: Other: Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
The revised Brief Fatigue Inventory (BFI)
The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity.
Measured: The primary outcome measure for this study is fatigue assessed on Friday during study week 6 by the BFI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start20 Jun 2016
- Primary completionApr 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester
- Investigators
- Luke Peppone, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758756
- Sponsor's protocol ID
- UCCS15115
- Status last verified
- Jul 2019
- First submitted
- 28 Apr 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McGuire J, Roscoe J, Reschke J, Lin PJ, Mustian K, Mattick L, Rieth K, Gilmore N, Spath K, Gada U, Peppone L. Feasibility and Efficacy of Reiki Versus Massage for Cancer-Related Fatigue in Patients With Breast and Prostate Cancer Receiving Hormone Therapy. J Natl Compr Canc Netw. 2026 Jun 9;24(7):1-8. doi: 10.6004/jnccn.2026.7010.
PubMed 42263755
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy
- ClinicalTrials.gov ID
- NCT02758756
- Acronym / sponsor ID
- UCCS15115
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
5.2.1 After providing written informed consent (and receiving a signed copy), the subject will complete an On-Study Data Form providing demographic and clinical data. Questions concerning the subject's experience with both Reiki and massage (and related treatments) and expectations for their efficacy in relieving fatigue are also included. Subjects will also complete a quality of life (QOL) questionnaire and sleep quality (SQ) questionnaire at time of consent.
5.2.2 Subjects will be asked to completed study questionnaires at home. They will have the option of completing questionnaires via the REDCap online survey system (see Section 6.10) or on paper. If they choose to complete paper questionnaires, they will be given a packet of study questionnaires at the time of consent. The questionnaire packet will consist of seven sets of questionnaires. Each set will have the Brief Fatigue Inventory (BFI), the Insomnia Severity Index (ISI), and a Symptom Inventory. In addition, the sixth and seventh sets of questionnaires will also include the Pittsburgh Sleep Quality Inventory (PSQI) to assess SQ, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) to assess QOL, and the Profile of Mood States (POMS). If they choose to complete questionnaires via REDCap, they will be asked to complete the same questionnaires through the online survey system. Subjects electing to use REDCap will also be given one set of paper questionnaires to be used in the event that computer access is not available when needed.
5.2.3 Subjects will be asked to complete one set of questionnaires (either through REDCap or on paper) each Friday night of the 2-week baseline and the 4-week intervention period. They will be asked to complete a final set on Friday of Week 10. A set of questionnaires takes about 10-20 minutes to complete.
5.2.4 Reminder phone calls or emails will be made by study personnel each Friday to assist the subject in remembering to complete the study forms. If they have chosen to complete paper questionnaires, they will also be instructed to return them in the provided stamped, pre-addressed envelope. (Permission will be obtained to leave messages on a subject's voicemail before any messages are left.)
5.3 An optional Heart Rate Variability (HRV) assessment will be done during study weeks 2 and 7 at the PEAK Laboratory at the URMC (see Section 6.7).
5.4 An optional fasting (8-hour) blood draw will be done at the URMC to estimate cytokines (CRP, IL-6, \& TNF-α) during study weeks 2 and 7 (see Section 6.8).
5.5 Treatment Arms:
5.5.1 Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart.
5.5.2 Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart.
5.5.3 Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart.
5.5.4 Scheduling arrangements will be made for the treatments prior to the initiation of the intervention.
5.5.6 Subjects will not be charged for the Reiki or massage treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Active comparator | Other: MassageSubjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart. |
| Two Reiki Tx | Experimental | Other: ReikiSubjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart. |
| Four Reiki Tx | Experimental | Other: ReikiSubjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageTreatments 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 | Massage |
| ReikiAlso: Energy TherapyReiki 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. | Other | Four Reiki Tx, Two Reiki Tx |
Primary outcome
The revised Brief Fatigue Inventory (BFI)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 42263755McGuire J, Roscoe J, Reschke J, Lin PJ, Mustian K, Mattick L, Rieth K, Gilmore N, Spath K, Gada U, Peppone L. Feasibility and Efficacy of Reiki Versus Massage for Cancer-Related Fatigue in Patients With Breast and Prostate Cancer Receiving Hormone Therapy. J Natl Compr Canc Netw. 2026 Jun 9;24(7):1-8. doi: 10.6004/jnccn.2026.7010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Peppone, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Reiki in people with Fatigue, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The revised Brief Fatigue Inventory (BFI) (time frame: The primary outcome measure for this study is fatigue assessed on Friday during study week 6 by the BFI.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.