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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440089
• Other study ID #: F31AT003021
• Secondary ID: F31AT003021
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 23, 2007
• Last updated: May 24, 2010
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Hands-on-Healing

Locations

Country	Name	City	State
United States	Clinical Research Center, UCSD Campus	La Jolla	California
United States	General Clinical Research Center, UCSD Medical Center	San Diego/Hillcrest	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple Fatigue Symptom Inventory
Secondary	Inflammatory Immune Markers
Secondary	Diurnal Cortisol Variability