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


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Multiple Fatigue Symptom Inventory

Principal Investigator

Shamini Jain, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Federal Government

Study ID:

F31 AT003021

NCT ID:

NCT00440089

Start Date:

October 2005

Completion Date:

September 2009

Related Keywords:

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

Name

Location

Clinical Research Center, UCSD Campus La Jolla, California  92037
General Clinical Research Center, UCSD Medical Center San Diego/Hillcrest, California  92103