Breast Cancer Clinical Trial
Official title:
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.
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