- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440089
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
May 24, 2010 updated by: University of California, San Diego
Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors.
Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.
Study Overview
Detailed Description
Please see our website at http://healing.ucsd.edu
for detailed information on the study.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Clinical Research Center, UCSD Campus
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San Diego/Hillcrest, California, United States, 92103
- General Clinical Research Center, UCSD Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Premenopausal and postmenopausal women between the ages of 18 to 70 years.
- Ability to give informed consent.
- Breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. We have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
- Stage I to III breast cancer survivors.
- Breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
- Breast cancer survivors with above-normative levels of fatigue.
Exclusion Criteria:
- Breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
- Patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
- Patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
- Patients with other inflammatory diseases that affect cytokine levels.
- Patients with a history of other cancers, and stage IV breast cancer.
- Patients undergoing current chemotherapy and/or radiotherapy.
- Men with breast cancer.
- Substance abuse/dependence.
- Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Multiple Fatigue Symptom Inventory
|
Secondary Outcome Measures
Outcome Measure |
---|
Inflammatory Immune Markers
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Diurnal Cortisol Variability
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shamini Jain, Ph.D., University of California, Los Angeles
- Principal Investigator: Paul J Mills, Ph.D., UCSD School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 23, 2007
First Submitted That Met QC Criteria
February 23, 2007
First Posted (Estimate)
February 26, 2007
Study Record Updates
Last Update Posted (Estimate)
May 25, 2010
Last Update Submitted That Met QC Criteria
May 24, 2010
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F31AT003021 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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