Reiki Therapy for Gynecological Cancer

(Reiki-Brachy Trial)

Overseen By David Samuel

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Utah

Disqualifiers: Prior brachytherapy, Cognitive conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Reiki Therapy for gynecological cancer?

Research shows that Reiki therapy, an energy-based treatment, can improve quality of life, reduce fatigue, and decrease anxiety and pain in cancer patients, including those undergoing chemotherapy. These benefits have been observed in studies involving breast cancer patients and other cancer types, suggesting potential positive effects for gynecological cancer patients as well. ^{1 2 3 4 5}

Is Reiki therapy safe for humans?

Reiki therapy appears to be generally safe, with no serious adverse effects reported in studies involving cancer patients. ^{1 5 6 7 8}

How is Reiki therapy different from other treatments for gynecological cancer?

Reiki therapy is unique because it is a form of energy healing that involves a practitioner placing their hands lightly on or near the patient's body to promote relaxation and healing, unlike conventional treatments like radiation or surgery that directly target the cancer cells. This non-invasive approach focuses on improving the patient's overall well-being and quality of life rather than directly treating the cancer itself. ^{9 10 11 12 13}

Research Team

Lindsay M. Burt

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for adults over 18 with certain gynecological cancers (endometrium, cervix, vagina, or vulva) who are about to receive their first brachytherapy as an outpatient. Participants must understand English/Spanish and be willing to sign consent forms. Those with prior brachytherapy or conditions affecting study compliance cannot join.

Inclusion Criteria

My cancer originates from the endometrium, cervix, vagina, or vulva.

Able to read and understand English and/or Spanish

I am 18 years old or older.

Exclusion Criteria

Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study

I have had brachytherapy for a gynecological cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety, pain, and depression using various scales, with assessments at the three-month follow-up time point

3 months

1 visit (in-person)

Treatment Details

Interventions

• Reiki Therapy

Trial Overview The study tests if Reiki therapy can improve the well-being of patients during the wait time between device placement and brachytherapy treatment for gynecological cancers. It compares outcomes like anxiety and pain in those receiving Reiki versus usual care before and three months after treatment.

Participant Groups

Group I: Reiki Therapy Experimental Treatment 1 Intervention

Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.

Group II: Standard of Care Active Control 1 Intervention

Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

In a study involving 70 breast cancer patients undergoing chemotherapy, those who received 6 sessions of Reiki therapy experienced significant improvements in quality of life and reductions in fatigue compared to a control group.

The results showed that Reiki therapy led to increased well-being scores and decreased fatigue levels, with statistically significant differences (P < .001), suggesting it can be an effective complementary treatment for enhancing the quality of life in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Reiki Therapy on Quality of Life and Fatigue Levels of Breast Cancer Patients Receiving Chemotherapy. Karaman, S., Tan, M.[2021]

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]

In a 3-year study involving 118 cancer patients, Reiki therapy significantly reduced anxiety scores from 6.77 to 2.28 in those who completed four treatment sessions, indicating its potential efficacy in managing anxiety.

Patients reported improvements in overall well-being, relaxation, pain relief, and sleep quality, suggesting that Reiki therapy could be a beneficial complementary treatment in hospital settings for addressing both physical and emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Birocco, N., Guillame, C., Storto, S., et al.[2012]

In a study involving 16 cancer patients, Reiki therapy significantly reduced fatigue and improved overall quality of life compared to a resting condition, with notable decreases in tiredness, pain, and anxiety after multiple sessions.

Participants receiving Reiki experienced measurable benefits, with fatigue levels decreasing over the course of 7 treatments, suggesting that Reiki could be a valuable complementary therapy for managing cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue. Tsang, KL., Carlson, LE., Olson, K.[2015]

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 study involving oncology patients, those who received five sessions of distant Reiki therapy experienced significantly lower levels of pain, anxiety, and fatigue compared to a control group that only received standard medical care.

The control group reported higher pain, stress, and fatigue levels, highlighting the potential benefits of incorporating Reiki as a complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Distant Reiki On Pain, Anxiety and Fatigue in Oncology Patients in Turkey: A Pilot Study. Demir, M., Can, G., Kelam, A., et al.[2019]

Reiki therapy was associated with significant improvements in the patient's absolute neutrophil count (ANC) during treatment for hepatitis C, allowing him to tolerate high-dose interferon therapy without interruptions due to neutropenia.

The study suggests a potential link between Reiki therapy and changes in biologic markers, as indicated by the correlation with a true random number generator (RNG), which may provide a novel method for assessing the effects of energetic healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Reiki therapy for a severely neutropenic patient with associated influences on a true random number generator. Morse, ML., Beem, LW.[2021]

Single-fraction external radiation therapy (1,000 rads to the whole pelvis) was administered to 30 patients with advanced gynecologic malignancies, successfully alleviating symptoms and maintaining a good quality of life without any significant acute side effects.

The treatment resulted in a mean overall survival of 8.4 months, with 13 patients surviving between 2 to 19 months post-treatment, suggesting that this approach could be a preferred palliative therapy for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction palliative pelvic radiation therapy in gynecologic oncology: 1,000 rads. Chafe, W., Fowler, WC., Currie, JL., et al.[2019]

The Indiana pouch technique for urinary diversion after pelvic surgery shows promise as a successful method for creating a continent urinary reservoir, with lower complication rates reported in various studies.

This case report highlights the use of the Indiana pouch in a 64-year-old woman after radical surgery for vaginal cuff squamous cell carcinoma, emphasizing the need for long-term observation to fully assess its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step by step Indiana pouch construction in a previously irradiated patient with a cervical cancer relapse. Llueca, A., Maazouzi, Y., Ponce, P., et al.[2023]

Intensity-modulated radiation therapy (IMRT) is an advanced technique that allows for more precise targeting of tumors in gynecologic cancers, minimizing damage to surrounding healthy tissues.

This review highlights the effectiveness of IMRT as both a primary treatment and a follow-up to surgery, showcasing its potential to improve patient outcomes while reducing adverse side effects associated with traditional radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in gynecologic malignancies: current status and future directions. Kochanski, JD., Mell, LK., Roeske, JC., et al.[2016]

In a study of 22 patients with vaginal recurrence of endometrial cancer, re-irradiation using brachytherapy, with or without external beam radiation therapy (EBRT), demonstrated a 3-year overall survival rate of 68.1%, indicating its efficacy as a salvage treatment.

The treatment was found to be safe, with no severe (grade 3 or higher) radiation-related toxicities reported, provided that the cumulative radiation dose to surrounding organs was kept below specified limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after definitive re-irradiation with 3D brachytherapy with or without external beam radiation therapy for vaginal recurrence of endometrial cancer. Ling, DC., Vargo, JA., Glaser, SM., et al.[2020]

Internal radiation therapy has been a treatment option for gynecological cancers for over a century, utilizing various radioactive sources either alone or in combination with other therapies.

Nurses play a crucial role in ensuring safe and comprehensive care for patients undergoing internal radiation therapy, emphasizing the importance of minimizing exposure risks during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing care update: internal radiation therapy. Lowdermilk, DL.[2007]

References

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

Effect of Reiki Therapy on Quality of Life and Fatigue Levels of Breast Cancer Patients Receiving Chemotherapy. [2021]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

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

The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. [2012]

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

Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue. [2015]

6. Thailand pubmed.ncbi.nlm.nih.gov

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

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

Effects of Distant Reiki On Pain, Anxiety and Fatigue in Oncology Patients in Turkey: A Pilot Study. [2019]

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

Benefits of Reiki therapy for a severely neutropenic patient with associated influences on a true random number generator. [2021]

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

Single-fraction palliative pelvic radiation therapy in gynecologic oncology: 1,000 rads. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Step by step Indiana pouch construction in a previously irradiated patient with a cervical cancer relapse. [2023]

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

Intensity-modulated radiation therapy in gynecologic malignancies: current status and future directions. [2016]

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

Outcomes after definitive re-irradiation with 3D brachytherapy with or without external beam radiation therapy for vaginal recurrence of endometrial cancer. [2020]

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

Nursing care update: internal radiation therapy. [2007]