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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
CD4+ and CD4+5RA+ lymphocyte counts; NK cell activity; TGF-beta1; sTNFRII; IL-1beta; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions
six weeks
No
Susan K Lutgendorf, PhD
Principal Investigator
Department of Psychology, University of Iowa
United States: Institutional Review Board
200305053
NCT00565305
June 2003
November 2009
Name | Location |
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Holden Comprehensive Cancer Center, University of Iowa | Iowa City, Iowa 52242 |