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

NCT00440089 | Completed Phase 2

• 1 other identifier: F31AT003021
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Cancer; Fatigue; Breast Cancer; Healing; Energy Healing; Complementary; Alternative; Immune; Cytokine; Hormone; Cortisol; Placebo; Mock Healing

Outcome Measures

Primary Outcomes (1)

• Multiple Fatigue Symptom Inventory

Secondary Outcomes (2)

• Inflammatory Immune Markers

• Diurnal Cortisol Variability

Interventions

Hands-on-Healing BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of California, San Diego: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Clinical Research Center, UCSD Campus

La Jolla, California, 92037, United States

Location

General Clinical Research Center, UCSD Medical Center

San Diego/Hillcrest, California, 92103, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shamini Jain, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Paul J Mills, Ph.D.

  UCSD School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 26, 2007
• Study Start: October 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 25, 2010

Record last verified: 2009-11

Locations

US (2)