Reiki/Energy Healing in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Effects of Energy Healing on Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065208
• Other study ID #: R21AT001120
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 18, 2003
• Last updated: September 20, 2012
• Start date: April 2005
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.

Description:

120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Newly diagnosed with prostate cancer

• Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

Exclusion criteria:

• Already involved in energy healing treatments

• Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons

• Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Reiki
Energy therapy - 8 biweekly sessions of 30 minutes
• Pretend Reiki
Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
• Rest / Guided Imagery
4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.		Each 30 minute session	No
Primary	To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels		Each 30 minute session	No
Primary	To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.		throughout study	Yes
Secondary	To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms		Throughout study	No