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NCT Number: NCT07581080

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

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.

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Key information

Conditions

Cancer Fatigue Fatigue Related to Cancer Treatment Immunotherapy Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Health Susan Samueli Integrative Health Institute, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Biofield therapy

Primary outcomes

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

    Time frame: Before and after each of the 6 weekly Reiki sessions

    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).

  2. Change in Pain

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

    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)

Secondary outcomes

  1. Change in Psychological Distress

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

    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).

  2. Inter-Brain Coherence Between Patient and Practitioner

    Time frame: Week 1 and Week 6 of each arm

    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.

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

    Time frame: Week 1 and Week 6 of the intervention arm

    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.

Other outcomes

  1. Recruitment Rate

    Time frame: Throughout recruitment period (up to approximately 16 weeks)

    Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period, multiplied by 100 and reported as a percentage.

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

    Time frame: Pre-intervention (baseline)

    Semi-structured interviews will be conducted with each participant to explore participants' experiences with Reiki and other supportive care tools, including perceived benefits, challenges, and overall acceptability.

  3. Retention Rate

    Time frame: 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).

    Retention rate will be calculated as the number of participants who complete the study divided by the number of participants enrolled, multiplied by 100 and reported as a percentage.

  4. Adherence to Reiki Sessions

    Time frame: Throughout the study intervention arm (Weeks 1 to 6)

    Adherence will be calculated as the number of completed Reiki sessions divided by the number of scheduled Reiki sessions, multiplied by 100 and reported as a percentage. Adherence may also be summarized as the proportion of participants completing all 6 sessions.

  5. Participant Satisfaction with Reiki Intervention

    Time frame: For participants in the immediate Reiki arm, satisfaction is measured 4 weeks following completion of the Reiki intervention. For participants in the waitlist control group, satisfaction will be measured at the end of the Reiki intervention arm (Week 17)

    Participant satisfaction will be assessed using a study satisfaction questionnaire administered after the intervention arm. This will be calculated using a 5-point Likert scale with higher scores indicating greater satisfaction.

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: Throughout study participation (up to approximately 16 weeks)

    Safety will be assessed by recording the number, type, and severity of treatment-emergent adverse events occurring after the start of the intervention. Adverse events will be summarized as counts and proportions of participants experiencing at least one adverse event. Adverse events monitoring will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Kagramanov, PhD

CONTACT

[email protected]

323-961-2728

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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