Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Healing Touch; Standard Treatment
Intervention type(s): Behavioral; Radiation
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Healing Touch; NK cytotoxicity; cytokines; fatigue