Status:
COMPLETED
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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-h...
Detailed Description
Please see our website at http://healing.ucsd.edu for detailed information on the study.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00440089
Start Date
October 1 2005
End Date
September 1 2009
Last Update
May 25 2010
Active Locations (2)
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1
Clinical Research Center, UCSD Campus
La Jolla, California, United States, 92037
2
General Clinical Research Center, UCSD Medical Center
San Diego/Hillcrest, California, United States, 92103