Reiki/Energy Healing in Prostate Cancer - Full Text View

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	Phase I Phase II

MedlinePlus related topics:

Anxiety Cancer Prostate Cancer

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Reiki: Experimental Energy therapy	Behavioral: Reiki Energy therapy

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

Contacts


Contact: Joan E Fox, Ph.D.	216-445-3874	foxj@ccf.org

Contact: Didier Allexandre, Ph.D.	216-444-0767	allexad@ccf.org

Locations


United States, Ohio
	Cleveland Clinic Foundation	Recruiting
	Cleveland, Ohio, United States, 44195
	Contact: Jeanette Potts, MD 216-445-7801 pottsj@ccf.org
	Contact: Eric Klein, MD 216-444-5591 kleine@ccf.org
	Principal Investigator: Joan Fox, Ph.D.

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Joan Fox, Ph.D.	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic Lerner College of Medicine ( Joan E. B. Fox, PhD )
Study ID Numbers:	R21 AT001120
First Received:	July 18, 2003
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00065208
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Prostate cancer

Reiki

Energy Healing

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065208