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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healing Touch
Standard Treatment
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Healing Touch, NK cytotoxicity, cytokines, fatigue

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Holden Comprehensive Cancer Center, University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healing Touch

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions

Secondary Outcome Measures

WBC, distress (POMS), sleep quality, days of interrupted treatment

Full Information

First Posted
November 28, 2007
Last Updated
March 13, 2017
Sponsor
University of Iowa
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT00565305
Brief Title
Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment
Official Title
Quality of Life and Immunity During Breast Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2003 (Actual)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Healing Touch, NK cytotoxicity, cytokines, fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healing Touch
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Healing Touch
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Standard Treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
WBC, distress (POMS), sleep quality, days of interrupted treatment
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Lutgendorf, PhD
Organizational Affiliation
Department of Psychology, University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holden Comprehensive Cancer Center, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment

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