NCT Number: NCT00440089
Effects of Hands-on-Healing vs. Touch for Fatigued 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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Clinical Research Center, UCSD Campus, La Jolla, California, United States
About this study
Please see our website at http://healing.ucsd.edu for detailed information on the study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
Multiple Fatigue Symptom Inventory
Secondary outcomes
-
Inflammatory Immune Markers
-
Diurnal Cortisol Variability
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
Registry information
Official study title
Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
Important dates
- Study start
- 2005
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Feb 26, 2007
- Registry last updated
- May 25, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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