Prostate CancerPhase 1/2NCT00065208
Reiki/Energy Healing in Prostate Cancer
A Phase 1/2 study testing Reiki, Pretend Reiki and Rest / Guided Imagery in people with Prostate Cancer, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Reiki, Pretend Reiki and Rest / Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed with prostate cancer
- Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Energy Healing on Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Reiki, Pretend Reiki, Rest / Guided Imagery
- Keywords
- Prostate cancer, Reiki, Energy Healing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiBehavioural
Also called Energy Therapy, Touch Therapy, Energy Healing
Energy therapy - 8 biweekly sessions of 30 minutes
Pretend ReikiBehavioural
Also called Touch
Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Rest / Guided ImageryBehavioural
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | Energy therapy Receives: Behavioral: Reiki |
| Pretend Reiki | Sham comparator | Not described Receives: Behavioral: Pretend Reiki |
| Rest / Guided Imagery | Other | Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes Receives: Behavioral: Rest / Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
Measured: Each 30 minute session
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
Measured: Each 30 minute session
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.
Measured: throughout study
Secondary outcomes (1)
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2003 (estimated)
- Study startApr 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Joan Fox, The Cleveland Clinic
- Investigators
- Joan Fox, Ph.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065208
- Sponsor's protocol ID
- R21AT001120
- Status last verified
- Sep 2012
- First submitted
- 18 Jul 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Healing on Prostate Cancer
- ClinicalTrials.gov ID
- NCT00065208
- Acronym / sponsor ID
- R21AT001120
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Reiki, Energy Healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Behavioral: ReikiEnergy therapy |
| Pretend Reiki | Sham comparator | Behavioral: Pretend Reiki |
| Rest / Guided Imagery | Other | Behavioral: Rest / Guided ImageryRest for pre-surgery outcomes Guided Imagery for post-surgery outcomes |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed with prostate cancer
- Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiAlso: Energy Therapy, Touch Therapy, Energy HealingEnergy therapy - 8 biweekly sessions of 30 minutes | Behavioural | Reiki |
| Pretend ReikiAlso: TouchTouch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes | Behavioural | Pretend Reiki |
| Rest / Guided ImageryAlso: Guided Imagery4 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) | Behavioural | Rest / Guided Imagery |
Primary outcome
To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
Time frame: Each 30 minute session
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
Time frame: Each 30 minute session
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.
Time frame: throughout study
1 secondary outcome
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Fox, Ph.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Reiki, Pretend Reiki and Rest / Guided Imagery in people with Prostate Cancer, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. (time frame: Each 30 minute session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.