Reiki/Energy Healing in Prostate Cancer - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00065208

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Behavioral: Reiki Behavioral: Pretend Reiki Behavioral: Rest / Guided Imagery	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Energy Healing on Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. [ Time Frame: Each 30 minute session ] [ Designated as safety issue: No ]
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels [ Time Frame: Each 30 minute session ] [ Designated as safety issue: No ]
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Reiki: Experimental Energy therapy	Behavioral: Reiki Energy therapy - 8 biweekly sessions of 30 minutes
Pretend Reiki: Sham Comparator	Behavioral: Pretend Reiki Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Rest / Guided Imagery: No Intervention Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes	Behavioral: 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)

Detailed 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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065208

Locations

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Joan Fox, Ph.D.

Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic Lerner College of Medicine ( Joan E. B. Fox, PhD )
Study ID Numbers:	R21 AT001120
Study First Received:	July 18, 2003
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00065208 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by The Cleveland Clinic:

Prostate cancer
Reiki
Energy Healing

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009