Clinical trial NCT00440089: Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
Official title: Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: Cancer
Fatigue
Breast Cancer
Healing
Energy Healing
Complementary
Alternative
Immune
Cytokine
Hormone
Cortisol
Placebo
Mock Healing
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-02-26
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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-healing, touch alone, or a control group.

Detailed description: Please see our website at http://healing.ucsd.edu for detailed information on the study.

Eligibility criteria: 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).

Primary outcomes:
measure: Multiple Fatigue Symptom Inventory
Secondary outcomes:
measure: Inflammatory Immune Markers
measure: Diurnal Cortisol Variability
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Clinical Research Center, UCSD Campus
state: California
city: San Diego/Hillcrest
country: United States
facility: General Clinical Research Center, UCSD Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Shamini Jain, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD School of Medicine
name: Paul J Mills, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: