Expired Study
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Cleveland, Ohio 44195


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R21 AT001120


NCT ID:

NCT00065208


Secondary ID:


Study Acronym:


Brief Title:

Reiki/Energy Healing in Prostate Cancer


Official Title:

Effects of Energy Healing on Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Male


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Cleveland Clinic


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

79


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joan Fox, Ph.D.
Principal Investigator
The Cleveland Clinic

Study Dates

Start Date:April 2005
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:September 2012
Last Changed Date:September 20, 2012
First Received Date:July 18, 2003

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.
Time Frame:throughout study
Safety Issues:True
Outcome Type:Primary Outcome
Measure:To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
Time Frame:Each 30 minute session
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
Time Frame:Each 30 minute session
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Reiki
Description:Energy therapy - 8 biweekly sessions of 30 minutes
Arm Name:Reiki
Other Name:Energy Therapy
Intervention Type:Behavioral
Name:Pretend Reiki
Description:Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Arm Name:Pretend Reiki
Other Name:Touch
Intervention Type:Behavioral
Name:Rest / Guided Imagery
Description: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)
Arm Name:Rest / Guided Imagery
Other Name:Guided Imagery

Study Arms

Study Arm Type:Other
Arm Name:Rest / Guided Imagery
Description:Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
Study Arm Type:Sham Comparator
Arm Name:Pretend Reiki
Study Arm Type:Experimental
Arm Name:Reiki
Description:Energy therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Cleveland Clinic
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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