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

NCT07581080 | Recruiting

• 1 other identifier: UCI 25-127
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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.

Conditions

Cancer; Immunotherapy; Fatigue Related to Cancer Treatment; Pain; Stress

Keywords

Reiki; Immunotherapy; Cancer; fatigue; pain; biofield therapy

Outcome Measures

Primary Outcomes (2)

• 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).

  Before and after each of the 6 weekly Reiki sessions

• 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)

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

Secondary Outcomes (3)

• Change in Psychological Distress

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

• Inter-Brain Coherence Between Patient and Practitioner

  Week 1 and Week 6 of each arm

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

  Week 1 and Week 6 of the intervention arm

Other Outcomes (6)

• Recruitment Rate

  Throughout recruitment period (up to approximately 16 weeks)

• Participant Beliefs, Perspectives and Experiences with Integrative Oncology Tools Via Qualitative Interview

  Pre-intervention (baseline)

• Retention Rate

  Throughout the study up until study completion, on average between 11-17 weeks depends on the arm participants are randomized to. For Immediate Reiki Arm (Week 11), For Waitlist Control Group (Week 17).

Study Arms (2)

Immediate Reiki Intervention

EXPERIMENTAL

Participants 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.

Other: Usui Reiki Intervention

Waitlist Control (Delayed Reiki Intervention)

OTHER

Participants 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).

Other: Usui Reiki Intervention

Interventions

Usui Reiki Intervention OTHER

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.

Also known as: Biofield therapy

Immediate Reiki Intervention; Waitlist Control (Delayed Reiki Intervention)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (2)

UCI Health Susan Samueli Integrative Health Institute

Irvine, California, 92617, United States

RECRUITING

UCI Health

Orange, California, 92868, United States

RECRUITING

Related Publications (16)

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• 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.

  PMID: 12652885 BACKGROUND

• 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.

  PMID: 24582620 BACKGROUND

• 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.

  PMID: 17351024 BACKGROUND

• 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.

  PMID: 21998438 BACKGROUND

• 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.

  PMID: 31046557 BACKGROUND

• 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.

  PMID: 19922247 BACKGROUND

• 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.

  PMID: 28874060 BACKGROUND

• 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.

  PMID: 25253110 BACKGROUND

• 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.

  PMID: 40451933 BACKGROUND

• 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.

  PMID: 29784734 BACKGROUND

• 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.

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• 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.

  PMID: 34724392 BACKGROUND

• 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.

  PMID: 29320654 BACKGROUND

• 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.

  PMID: 33197221 BACKGROUND

• Blidner AG, Choi J, Cooksley T, Dougan M, Glezerman I, Ginex P, Girotra M, Gupta D, Johnson D, Shannon VR, Suarez-Almazor M, Rapoport BL, Anderson R. Cancer immunotherapy-related adverse events: causes and challenges. Support Care Cancer. 2020 Dec;28(12):6111-6117. doi: 10.1007/s00520-020-05705-5. Epub 2020 Aug 28.

  PMID: 32857220 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain; Fatigue

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia Kagramanov, PhD

CONTACT

323-961-2728; dkagrama@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 12, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)