Reiki/Energy Healing in Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

July 18, 2003

Last Updated Date

October 27, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.

Change History

Complete list of historical versions of study NCT00065208 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms

Descriptive Information

Brief Title ^ICMJE

Reiki/Energy Healing in Prostate Cancer

Official Title ^ICMJE

Effects of Energy Healing on Prostate Cancer

Brief 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.

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Behavioral: Reiki
Behavioral: Pretend Reiki
Behavioral: Rest / Guided Imagery

Study Arms / Comparison Groups

Experimental: Energy therapy
No Intervention: Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00065208

Responsible Party

Joan E. B. Fox, PhD, Cleveland Clinic Lerner College of Medicine

Study ID Numbers ^ICMJE

R21 AT001120

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Joan Fox, Ph.D.

Cleveland Clinic

Information Provided By

The Cleveland Clinic

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP