Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors

University of California, San Diego2 sites in 1 country76 target enrollmentOctober 2005

ConditionsBreast Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of California, San Diego
Enrollment: 76
Locations: 2
Primary Endpoint: Multiple Fatigue Symptom Inventory
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

September 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Factorial

Sex

Female

Investigators

Sponsor

University of California, San Diego

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).