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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00565305
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Susan Lutgendorf, University of Iowa

Tracking Information
First Submitted Date  ICMJE November 28, 2007
First Posted Date  ICMJE November 29, 2007
Last Update Posted Date March 15, 2017
Actual Study Start Date  ICMJE July 2003
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)		 NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions [ Time Frame: six weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2007)		 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)		 WBC, distress (POMS), sleep quality, days of interrupted treatment [ Time Frame: six weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2007)		 WBC, distress (POMS), sleep quality, and days of interrupted treatment [ Time Frame: six weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment
Official Title  ICMJE Quality of Life and Immunity During Breast Cancer Treatment
Brief Summary

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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2007)		 150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00565305
Other Study ID Numbers  ICMJE 200305053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Susan Lutgendorf, University of Iowa
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Iowa
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Department of Health and Human Services
Investigators  ICMJE
Principal Investigator: Susan K Lutgendorf, PhD Department of Psychology, University of Iowa
PRS Account University of Iowa
Verification Date March 2017

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