|Grant Number:||5R21CA102515-02 Interpret this number|
|Primary Investigator:||Lutgendorf, Susan|
|Organization:||University Of Iowa|
|Project Title:||Healing Touch, Immunity, and Fatigue in Breast Cancer|
DESCRIPTION (provided by applicant): 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 and chemotherapy. The significance of this study is that it will provide preliminary data on a) feasibility of this intervention in a breast cancer population, b) the impact, if any, or HT on these intermediate outcome measures, c) information on mechanisms of action, and d) whether the magnitude of the impact is large enough to be sufficient clinical significance to be examined in future Phase II and III dose and efficacy trials.