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CancerNCT07581080

Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study

A study testing Usui Reiki Intervention in people with Cancer and Immunotherapy, run by University of California, Irvine at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Usui Reiki Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
20 Apr 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be greater than 18 years of age.
  • Currently diagnosed with cancer.
  • Actively receiving immunotherapy treatment with ICI (PD1 or -PD-L1 inhibitor (single-agent immunotherapy or immunotherapy in combination with other agents; also including the use of steroids if applicable)
  • Report clinically significant fatigue over the past 7 days.
  • Able to travel to the study site to receive Reiki treatments once a week.
  • Understanding and willing to complete all study procedures.
  • Capable of giving written informed consent.
  • Proficient ability to speak, read, and write in English or Spanish.

Who cannot join

  • Individuals currently receiving or received Reiki treatment in the past 30 days
  • Currently diagnosed with a severe psychiatric illness (i.e. schizophrenia, dementia, major depression with suicidal ideations)
  • Currently pregnant or intending to become pregnant during the study timeframe

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dalia Kagramanov, PhD contact

323-961-2728

dkagrama@hs.uci.edu

United States2 sites, 2 recruiting

  • UCI Health Susan Samueli Integrative Health Institute

    Irvine, California, 92617

    Dalia Kagramanov, PhD, 323-961-2728, dkagrama@hs.uci.edu

    Dalia Kagramanov, PhD

    Recruiting

  • UCI Health

    Orange, California, 92868

    Dalia Kagramanov, PhD, 3239612728, dkagrama@hs.uci.edu

    Recruiting

Other trials in United States

About this study

Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms.

The purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care.

Read more

The secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement.

Lastly, the third aim is to explore participants' experiences with Reiki through guided interviews.

Participants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups:

Immediate Reiki Group:

If participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience.

Waitlist Group:

If they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience.

The investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.

Being tested
Usui Reiki Intervention
Keywords
Reiki, Immunotherapy, Cancer, fatigue, pain, biofield therapy
Medical subject headings
Neoplasms, Pain, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usui Reiki InterventionOther

    Also called Biofield therapy

    This study evaluates a standardized Usui Reiki intervention delivered by a trained Reiki Master (Level III). Participants will receive six weekly, in-person sessions, each lasting approximately 30 minutes, in a quiet clinical setting. During each session, participants rest in a reclined position with minimal sensory stimulation (e.g., optional blindfold and earplugs), while the practitioner places their hands just above the body at standardized positions.

    The intervention is structured to ensure consistency across participants, including fixed session frequency, duration, and a single trained practitioner. It is implemented in patients undergoing active immunotherapy and includes multimodal assessments, such as patient-reported outcomes, electroencephalogram (EEG) measurements, and blood-based biomarkers collected at specified time points to explore potential clinical and biological effects.

Study groups in NCT07581080
Study groupRoleWhat they receive
Immediate Reiki InterventionExperimentalParticipants randomized to this arm will receive the Reiki intervention immediately following the qualitative interview portion of the study. The intervention consists of six weekly, in-person Reiki sessions delivered by a trained practitioner, with each session lasting approximately 30 minutes in a calm, quiet setting. Participants will complete patient-reported outcome measures before and after each Reiki session to assess symptoms of fatigue, pain, and emotional distress. In addition, participants at Week 1 and Week 6 will undergo non-invasive electroencephalogram (EEG) measurements and blood sample collection to explore potential neurophysiological and biological changes. Following the intervention, participants will complete a satisfaction survey.
Receives: Other: Usui Reiki Intervention
Waitlist Control (Delayed Reiki Intervention)OtherParticipants randomized to this arm will first complete a six-week observation period without receiving Reiki following the qualitative interview. During this time, participants will complete regular symptom assessments. They will attend two in-person visits (Week 1 and Week 6), which will include a Sham Reiki session, and EEG measurement. Following the observation period, participants will complete a four-week washout period and then cross over to receive the Reiki intervention, consisting of six weekly, 30-minute sessions delivered by a trained practitioner (as described in the Experimental arm).
Receives: Other: Usui Reiki Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score)

    Fatigue will be assessed using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), a validated self-report questionnaire measuring general, physical, emotional, and mental fatigue, as well as vigor. Scores will be used to evaluate changes in fatigue severity over time. Total scores range from -24 to 96, with higher scores indicating greater fatigue (worse outcome).

    Measured: Before and after each of the 6 weekly Reiki sessions

  2. Change in Pain

    Pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain (higher scores = worse outcome)

    Measured: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session)

Secondary outcomes (3)

  1. Change in Psychological Distress

    Psychological distress will be measured using the Rotterdam Symptom Checklist (RSCL), which assesses emotional symptoms such as anxiety and depression. Scores typically range from 0 to 100 (standardized scale), with higher scores indicating greater psychological distress (worse outcome).

    Measured: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session).

  2. Inter-Brain Coherence Between Patient and Practitioner

    Electroencephalogram (EEG) recordings will be collected to explore changes in brain activity associated with the intervention. EEG data will be collected via Brain Products EEG system with 32-channel water-based nets, a sampling frequency of 500Hz, and electrode impedance below 50 KΩ. EEG caps from the participant and practitioner will be attached to the same EEG amplifier (BrainAmp) ensuring millisecond-precision alignment. The study will compute Power Spectral Density (PSD) in all standard EEG frequency bands as well as hyper scanning measures of inter-brain coherence.

    Measured: Week 1 and Week 6 of each arm

  3. Change in Inflammatory Biomarkers (Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels)

    Blood samples will be collected to assess potential changes in inflammatory biomarkers associated with the intervention. Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels will be quantified using commercially available multiplex and ELISA kits.

    Measured: Week 1 and Week 6 of the intervention arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start20 Apr 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Crossover
Model description
This study uses a randomized crossover design. Participants are assigned to one of two groups: an Immediate intervention group or a waitlist control group. The immediate group receives weekly Reiki sessions for six weeks. The waitlist group first completes a six-week observation period, during which no active Reiki is provided, followed by a four-week washout period, and then crosses over to receive the same six-week Reiki intervention. This design allows all participants to receive the intervention while enabling comparison between those receiving Reiki and those not yet receiving it. The crossover approach also allows participants to serve as their own comparison over time, supporting evaluation of changes in symptoms across different study periods.
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581080
Sponsor's protocol ID
STUDY00000374
Status last verified
Jul 2026
First submitted
10 Apr 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vitale A. An integrative review of Reiki touch therapy research. Holist Nurs Pract. 2007 Jul-Aug;21(4):167-79; quiz 180-1. doi: 10.1097/01.HNP.0000280927.83506.f6.

    PubMed 17627194

  • Miles P, True G. Reiki--review of a biofield therapy history, theory, practice, and research. Altern Ther Health Med. 2003 Mar-Apr;9(2):62-72.

    PubMed 12652885

  • Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28.

    PubMed 24582620

  • Tsang KL, Carlson LE, Olson K. Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue. Integr Cancer Ther. 2007 Mar;6(1):25-35. doi: 10.1177/1534735406298986.

    PubMed 17351024

  • Birocco N, Guillame C, Storto S, Ritorto G, Catino C, Gir N, Balestra L, Tealdi G, Orecchia C, Vito GD, Giaretto L, Donadio M, Bertetto O, Schena M, Ciuffreda L. The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Am J Hosp Palliat Care. 2012 Jun;29(4):290-4. doi: 10.1177/1049909111420859. Epub 2011 Oct 13.

    PubMed 21998438

  • Zucchetti G, Candela F, Bottigelli C, Campione G, Parrinello A, Piu P, Vassallo E, Fagioli F. The Power of Reiki: Feasibility and Efficacy of Reducing Pain in Children With Cancer Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2019 Sep/Oct;36(5):361-368. doi: 10.1177/1043454219845879. Epub 2019 May 3.

    PubMed 31046557

  • vanderVaart S, Gijsen VM, de Wildt SN, Koren G. A systematic review of the therapeutic effects of Reiki. J Altern Complement Med. 2009 Nov;15(11):1157-69. doi: 10.1089/acm.2009.0036.

    PubMed 19922247

  • McManus DE. Reiki Is Better Than Placebo and Has Broad Potential as a Complementary Health Therapy. J Evid Based Complementary Altern Med. 2017 Oct;22(4):1051-1057. doi: 10.1177/2156587217728644. Epub 2017 Sep 5.

    PubMed 28874060

  • Gonella S, Garrino L, Dimonte V. Biofield therapies and cancer-related symptoms: a review. Clin J Oncol Nurs. 2014 Oct;18(5):568-76. doi: 10.1188/14.CJON.568-576.

    PubMed 25253110

  • Sayer M, Agrawal P, Ng DQ, Kagramanov D, Trudeau J, Othy S, Acharya MM, Chan A. Incidence and predictors of immune checkpoint inhibitor treatment-related cognitive impairment in a racial and ethnic diverse population. Support Care Cancer. 2025 Jun 2;33(6):523. doi: 10.1007/s00520-025-09560-0.

    PubMed 40451933

  • Thompson JA. New NCCN Guidelines: Recognition and Management of Immunotherapy-Related Toxicity. J Natl Compr Canc Netw. 2018 May;16(5S):594-596. doi: 10.6004/jnccn.2018.0047.

    PubMed 29784734

  • Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available.

    PubMed 28881921

  • Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021 Dec 20;39(36):4073-4126. doi: 10.1200/JCO.21.01440. Epub 2021 Nov 1.

    PubMed 34724392

  • Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018 Jan 11;378(2):158-168. doi: 10.1056/NEJMra1703481. No abstract available.

    PubMed 29320654

  • Bagchi S, Yuan R, Engleman EG. Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance. Annu Rev Pathol. 2021 Jan 24;16:223-249. doi: 10.1146/annurev-pathol-042020-042741. Epub 2020 Nov 16.

    PubMed 33197221

Questions about this trial

What is this clinical trial studying?

A study testing Usui Reiki Intervention in people with Cancer and Immunotherapy, run by University of California, Irvine at 2 sites 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dalia Kagramanov, PhD (323-961-2728, dkagrama@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score) (time frame: Before and after each of the 6 weekly Reiki sessions). The study lists 2 primary outcomes in all. 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 NCT07581080, which also lists 16 linked publications.

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 10 Jul 2026.

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