Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors

Completed · Phase 2/Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00440089

Run by

University of California, San Diego

People needed

76

Starts

2005-10-01

Expected to finish

2009-09-01

Last updated by the study team

2010-05-25

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Clinical Research Center, UCSD Campus — La Jolla, California, United States
• General Clinical Research Center, UCSD Medical Center — San Diego/Hillcrest, California, United States

Full record on ClinicalTrials.gov

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