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Quality of Life and Immunity During Breast Cancer Treatment

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Quality of Life and Immunity During Breast Cancer 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.

Inclusion Criteria:

- Breast cancer patients who have received either a mastectomy or breast conservative

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

CD4+ and CD4+5RA+ lymphocyte counts; NK cell activity; TGF-beta1; sTNFRII; IL-1beta; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions

Outcome Time Frame:

six weeks

Safety Issue:


Principal Investigator

Susan K Lutgendorf, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Psychology, University of Iowa


United States: Institutional Review Board

Study ID:




Start Date:

June 2003

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • healing touch
  • NK cytotoxicity
  • cytokines
  • fatigue
  • acute skin reaction
  • Breast Neoplasms



Holden Comprehensive Cancer Center, University of IowaIowa City, Iowa  52242