Medical Reiki for Breast Cancer

Overseen By Camille Garrett, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Uncontrolled psychiatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

32 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Medical Reiki for Breast Cancer?

Research suggests that Reiki, a form of energy healing, may help improve mood and quality of life for cancer patients undergoing chemotherapy, with some patients reporting feeling better after sessions. Although not statistically significant, more than half of the patients in one study experienced clinically significant improvements in symptoms and well-being. ^{1 2 3 4 5}

Is Reiki therapy safe for humans?

Reiki therapy appears to be generally safe, with no serious side effects reported in studies involving cancer patients. ^{4 5 6 7 8}

How does Medical Reiki treatment differ from other treatments for breast cancer?

Medical Reiki is a complementary therapy that involves energy healing, which is different from conventional breast cancer treatments like surgery, radiation, or chemotherapy. It focuses on promoting relaxation and reducing stress, which may help improve overall well-being during cancer treatment. ^{9 10 11 12 13}

What is the purpose of this trial?

This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery.

Research Team

Alyson Moadel, PhD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

This trial is for underserved women preparing for breast cancer surgery. It's designed to see if Medical Reiki before the operation can help with their emotional well-being and recovery.

Inclusion Criteria

From Bronx County, NY

My breast cancer is at an early to mid-stage (0-III).

I am scheduled for a mastectomy, with or without reconstruction, within 2 weeks.

Exclusion Criteria

Uncontrolled psychiatric co-morbidities

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-operative Intervention

Participants receive Medical Reiki© or Sham Reiki before surgery to assess impact on recovery and quality of life

1 day

1 visit (in-person)

Follow-up

Participants are monitored for psychosocial and medical recovery metrics post-surgery

2 months

3 visits (virtual or telephone)

Treatment Details

Interventions

• Medical Reiki
• Sham Reiki

Trial Overview The study is testing the effects of pre-operative Medical Reiki compared to Sham Reiki, which does not involve actual energy work, on patients' psychosocial health and post-surgery recovery.

Participant Groups

Group I: Group A- Medical Reiki Active Control 1 Intervention

The energy medicine will be delivered to the study participant immediately pre-op. The Reiki practitioner will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the practitioner will mainly be silent for the 30 minute session.

Group II: Group B- Sham Reiki Placebo Group 1 Intervention

Patients will be recruited to receive "Sham" Reiki before surgery. The non-Reiki healer will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the non-Reiki healer will mainly be silent for the 30 minute session.

Medical Reiki is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Reiki for:

• Complementary therapy for stress relief
• Anxiety management
• Pain management

Approved in European Union as Reiki for:

• Wellness and relaxation
• Supportive care for cancer patients

Approved in Canada as Reiki for:

• Holistic health practice
• Stress reduction

Approved in Japan as Reiki for:

• Traditional healing practice
• Spiritual well-being

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Medical Reiki Works, Inc

Collaborator

Trials

1

Recruited

30+

Findings from Research

In a study of 124 cardiac surgery patients, Reiki therapy did not significantly reduce anxiety and depression compared to conventional care, but it did improve spiritual well-being in the intervention group (n=31).

While the intervention group experienced lower levels of anxiety and depression, these differences were not statistically significant, suggesting that Reiki may enhance overall well-being rather than directly impact anxiety and depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reiki protocol for preoperative anxiety, depression, and well-being: a non-randomized controlled trial. Santos, CBRD., Gomes, ET., Bezerra, SMMDS., et al.[2022]

In a randomized controlled trial involving 110 breast cancer patients, self-efficacy for coping with cancer was found to enhance the effects of Reiki treatment on reducing anxiety and improving mood.

Patients with higher self-efficacy experienced greater benefits from Reiki, suggesting that psychological factors can influence the effectiveness of complementary therapies in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Efficacy for Coping with Cancer Enhances the Effect of Reiki Treatments During the Pre-Surgery Phase of Breast Cancer Patients. Chirico, A., D'Aiuto, G., Penon, A., et al.[2017]

In a pilot study involving 36 cancer patients who received 5 sessions of individualized Reiki, over half reported feeling better after treatment, suggesting potential benefits for symptom relief and well-being.

While the results were clinically significant, they were not statistically significant when compared to a control group of 14 patients, indicating that more research is needed to confirm the efficacy of Reiki in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study. Siegel, P., da Motta, PM., da Silva, LG., et al.[2017]

In a pilot study involving 36 breast cancer patients, both Reiki therapy and companionship during chemotherapy were found to improve quality of life and mood compared to usual care.

Reiki therapy was well-received, rated as relaxing, and showed no side effects, suggesting it is a safe and feasible complementary intervention during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Reiki therapy and companionship on quality of life, mood, and symptom distress during chemotherapy. Orsak, G., Stevens, AM., Brufsky, A., et al.[2014]

A qualitative study involving 10 women who received reiki after cancer treatment revealed that participants experienced emotional release, pain relief, and improved overall well-being, including better sleep and reduced depression.

The findings suggest that reiki may serve as a beneficial complementary therapy for enhancing the quality of life in women with cancer, despite participants initially having limited understanding of the practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory study of reiki experiences in women who have cancer. Kirshbaum, MN., Stead, M., Bartys, S.[2017]

Reiki therapy significantly reduced stress levels in caregivers of cancer patients, as indicated by lower Caregiver Strain Index (CSI) scores after 6 weeks of treatment compared to a sham group.

The study also found that Reiki was effective in lowering systolic and diastolic blood pressure and pulse rate, although it did not significantly affect salivary cortisol levels, suggesting that while Reiki may help with stress relief, its mechanism may not involve changes in cortisol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Reiki on the stress level of caregivers of patients with cancer: Qualitative and single-blind randomized controlled trial. Özcan Yüce, U., Taşcı, S.[2021]

Reiki is considered a safe form of energy therapy that may help enhance the body's natural healing abilities, reduce inflammation, and alleviate pain and stress, with no serious adverse effects reported.

The article discusses the application of Reiki in oncology services, suggesting its potential role in supporting cancer patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Reiki on symptom management in oncology. Demir, M., Can, G., Celek, E.[2019]

In a pilot study involving 32 women undergoing breast biopsy, Reiki therapy did not show significant effectiveness in reducing anxiety or depression compared to conventional care.

Both groups had comparably low baseline anxiety levels that decreased over time, suggesting that the natural reduction in anxiety may have limited the ability to observe any potential benefits of the Reiki intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast biopsy and distress: feasibility of testing a Reiki intervention. Potter, PJ.[2007]

A survey of 941 breast cancer cases with positive surgical margins indicated that doses of radiotherapy greater than 60 Gy may improve local control, particularly in postmenopausal patients.

Short course irradiation methods, like the Canadian protocol, and accelerated partial breast irradiation have been introduced to reduce patient burden, but the optimal timing of postoperative chemotherapy and irradiation remains crucial for minimizing distant metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy in breast cancer]. Karasawa, K., Hirowatari, H., Izawa, H., et al.[2009]

Radiation therapy (RT) is crucial in breast cancer treatment as it helps eliminate remaining cancer cells after surgery, significantly lowering the chances of local recurrence and improving survival rates for early-stage patients.

The article discusses various RT techniques, including hypofractionated RT and partial breast irradiation, highlighting their effectiveness in both noninvasive and invasive breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy in the management of breast cancer. Yang, TJ., Ho, AY.[2018]

In a systematic review of 27 observational studies involving patients with HR+/HER2- advanced and metastatic breast cancer in Japan, key independent prognostic factors for overall survival were identified, including a short disease-free interval, the number of metastatic organs, and liver metastasis.

Liver metastasis was particularly significant, with a hazard ratio of ≥2.8 indicating a strong association with poor overall survival, while the disease-free interval and number of metastatic organs also showed moderate associations (hazard ratios of 1.3-2.8).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic literature review of prognostic factors in patients with HR+/HER2- advanced breast cancer in Japan. Hattori, M., Novick, D., Takaura, K., et al.[2022]

A study of 1,292 elderly women with stage I, estrogen receptor-positive breast cancer showed that after 2004, when new guidelines were introduced, there was a significant decrease in the use of radiation therapy (RT), particularly among women aged 80 and older, where RT use dropped from 80% to 41%.

Factors influencing the omission of RT included older age, higher comorbidity scores, smaller tumor sizes, and the absence of axillary surgery, indicating that patient and tumor characteristics, along with institutional practices, play a crucial role in the adoption of treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of guideline changes on use or omission of radiation in the elderly with early breast cancer: practice patterns at National Comprehensive Cancer Network institutions. McCormick, B., Ottesen, RA., Hughes, ME., et al.[2022]

Over the past 25 years, breast cancer treatment in Japan has evolved significantly, with a shift towards less invasive procedures and the reduced use of Halsted's surgical method, including debates on omitting axillary dissection.

The introduction of advanced therapies such as tamoxifen, LH-RH analogs, aromatase inhibitors, and new 5-FU derivatives like S-1 and capecitabine has led to improved treatment outcomes, making Japan's results comparable to those in Western countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in breast cancer treatment over a quarter of a century]. Tominaga, T.[2007]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Reiki protocol for preoperative anxiety, depression, and well-being: a non-randomized controlled trial. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Self-Efficacy for Coping with Cancer Enhances the Effect of Reiki Treatments During the Pre-Surgery Phase of Breast Cancer Patients. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of Reiki therapy and companionship on quality of life, mood, and symptom distress during chemotherapy. [2014]

5. England pubmed.ncbi.nlm.nih.gov

An exploratory study of reiki experiences in women who have cancer. [2017]

6. Scotland pubmed.ncbi.nlm.nih.gov

Effect of Reiki on the stress level of caregivers of patients with cancer: Qualitative and single-blind randomized controlled trial. [2021]

7. Thailand pubmed.ncbi.nlm.nih.gov

Effect of Reiki on symptom management in oncology. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Breast biopsy and distress: feasibility of testing a Reiki intervention. [2007]

9. Japan pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy in breast cancer]. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Radiation therapy in the management of breast cancer. [2018]

11. England pubmed.ncbi.nlm.nih.gov

A systematic literature review of prognostic factors in patients with HR+/HER2- advanced breast cancer in Japan. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of guideline changes on use or omission of radiation in the elderly with early breast cancer: practice patterns at National Comprehensive Cancer Network institutions. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

[Progress in breast cancer treatment over a quarter of a century]. [2007]