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Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment

This study has been completed.
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Susan Lutgendorf, University of Iowa
ClinicalTrials.gov Identifier:
NCT00565305
First received: November 28, 2007
Last updated: March 13, 2017
Last verified: March 2017
November 28, 2007
March 13, 2017
July 2003
June 2008   (Final data collection date for primary outcome measure)
NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions [ Time Frame: six weeks ]
CD4+ and CD4+5RA+ lymphocyte counts; NK cell activity; TGF-beta1; sTNFRII; IL-1beta; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions [ Time Frame: six weeks ]
Complete list of historical versions of study NCT00565305 on ClinicalTrials.gov Archive Site
WBC, distress (POMS), sleep quality, days of interrupted treatment [ Time Frame: six weeks ]
WBC, distress (POMS), sleep quality, and days of interrupted treatment [ Time Frame: six weeks ]
Not Provided
Not Provided
 
Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment
Quality of Life and Immunity During Breast Cancer Treatment

The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as a patient is receiving treatment for cancer. Treatments include light touch on specific points on the body as well as around the body, to increase well-being and support the body's ability to heal. Healing Touch has been shown to increase relaxation and well-being and to decrease anxiety, pain, and treatment side effects in a variety of illnesses including cancer. Although Healing Touch is frequently used by cancer patients along with their medical treatments, very little is understood about the effects of this treatment on the immune system. The immune system is known to be important in the body's response to fighting cancer. We are studying Healing Touch to help us understand whether or not these treatments are effective in supporting the immune system during breast cancer treatment

Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among early stage breast cancer patients during radiotherapy.

Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with radiation damage and acute skin reactions in early stage breast cancer patients during radiotherapy.

Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early stage breast cancer patients during radiation treatment.

Breast cancer patients use Complementary and Alternative Medicine (CAM) in greater proportions than any other group of cancer patients. The primary reason breast cancer patients cite for use of CAM is strengthening the immune system. Healing touch (HT) is a CAM treatment frequently used by cancer patients to reduce adverse side effects of chemotherapy and radiation and to enhance immunity. HT is classified by NIH as a "biofield" therapy as its effects are proposed to be secondary to manipulation of "energy fields" around the body of a patient. A recent meta-analysis has demonstrated relatively large effects of HT on well-being and on physiological parameters, even from brief treatments. However, to date, there are no data on the effects of HT on immune function among breast cancer patients during treatment. This is particularly important as several immune parameters show long-term suppression or alteration, particularly after combined adjuvant chemotherapy and radiation among breast cancer patients. Additionally, there are no data on the effects of HT on the common side effects of breast cancer treatment which can include profound fatigue and radiation-induced skin damage. Physiological mechanisms underlying possible effects of HT are also poorly understood. This study is designed to reduce this knowledge gap by examining how HT affects cellular immune function and biomarkers related to two of the most problematic side effects of breast cancer treatment, fatigue and radiation-induced tissue damage. Effects on the subjective experience of fatigue and clinician rated skin damage will also be noted. Participants will be 42 early stage breast cancer patients who are receiving a standard course of radiotherapy following breast conservation surgery or mastectomy who have either had chemotherapy or not

The significance of the project is as follows. If positive effects are demonstrated on intermediate outcomes such as immune parameters, markers of radiation damage, and/or fatigue, follow-up studies would be warranted examining effects of HT on a) recurrence and survival, b) incidence of long term side effects of radiation, c) quality of life among breast cancer patients. Additionally, if effects of HT are demonstrated, a critical examination of putative mechanisms of action, using controls for effect of attention, expectation, and other placebo effects will be warranted.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Supportive Care
Breast Cancer
  • Behavioral: Healing Touch
    Healing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association
  • Radiation: Standard Treatment
    4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy
  • Experimental: Healing Touch
    Healing Touch + Standard Treatment Healing Touch treatments daily following standard Radiation Therapy. Standard radiation therapy is part of their medical care and is not administered as part of this study. Protocol of 4 HT techniques will be used including Pain Drain, Chakra connection, Magnetic Unruffling, and Mind Clearing. Treatments will be approximately 20-30 minutes.
    Interventions:
    • Behavioral: Healing Touch
    • Radiation: Standard Treatment
  • Active Comparator: Usual Care
    Standard Treatment. These patients receive usual medical care but no additional intervention. Standard treatment is not administered as part of this study but as part of their medical treatment.
    Intervention: Radiation: Standard Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
November 2009
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast cancer patients who have received either a mastectomy or breast conservative surgery
  • Diagnosis of Stage I-IIIa breast cancer,
  • Receiving either chemotherapy + radiation or radiation alone

Exclusion Criteria:

  • Past history of cancer
  • Recurrent cancer
  • Greater than Stage IIIa breast cancer
  • History of immunosuppressive disorders (e.g. HIV, AIDS, hepatitis, etc.)
  • On immunosuppressive medications
  • On corticosteroids (e.g. Prednisone)
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00565305
200305053
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Susan Lutgendorf, University of Iowa
University of Iowa
Department of Health and Human Services
Principal Investigator: Susan K Lutgendorf, PhD Department of Psychology, University of Iowa
University of Iowa
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP