This proposal directly addresses the goal of PA-08-121 Symptom Interactions in Cancer and Immune Disorders issued by the National Institute of Nursing Research (NINR), National Cancer Institute (NCI), National Center on Complementary and Alternative Medicine (NCCAM), and National Institute on Aging (NIA), National Institutes of Health (NIH), soliciting research to "design and test interventions targeted to interacting or clustered symptoms that are hypothesized to lead to beneficial patient outcomes." The overall goal of this biobehavioral, randomized clinical trial (RCT) is to examine the effects of an innovative, nonpharmacological symptom management modality, cranial microcurrent electrical stimulation (CES,) for ameliorating psychoneurologic symptoms (depression, anxiety, fatigue, pain and sleep disturbances) in women (N=150) with early-stage breast cancer (BC) over the adjuvant chemotherapy treatment period. CES is a non-invasive, portable, and easily standardized modality that been approved by the FDA as a drug-free treatment for depressed mood, anxiety, pain and insomnia. The proposed study builds on a NCI-funded pilot, feasibility study (R21 CA106149, Lyon, PI) of CES in women receiving chemotherapy for breast cancer. Results from our pilot study support the safety and feasibility of the use of CES during the adjuvant chemotherapy phase in women with early-stage breast cancer. Building on the findings of the pilot study, the primary aim of this RCT is to compare the effects of CES to sham CES over time on symptoms of depression, anxiety, fatigue, pain and sleep disturbances in women with early-stage breast cancer receiving adjuvant chemotherapy. Exploratory aims are to (1) explore the relationships among selected markers of inflammation (tumor necrosis factor alpha [TNF-1], interleukin-6 [IL-6], interleukin-IL1-2 [IL1-2], and C-reactive protein [CRP]), symptoms and QOL;(2) examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances and pain form a cluster;and (3) examine the effects of CES on QOL.
The specific aims will be accomplished using a prospective, randomized, sham-controlled, double-blinded clinical trial. A longitudinal repeated measures model will be used to compare the effects of the CES intervention to the sham control group over the adjuvant chemotherapy period. These findings could have valuable implications for symptom management of multiple common, distressing symptoms in oncology. Further, the proposed study will add to scientific understanding of the pattern of symptoms over time, the relationships of symptoms with markers of inflammation, and provide data for exploring the clustering of these symptoms.

Public Health Relevance

The results of this study have the potential to reduce the discomforts of cancer chemotherapy in women receiving chemotherapy for breast cancer, thereby enhancing quality of life. Results from this study may also help to identify more clearly the biological causes for common, distressing symptoms.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA127446-04
Application #
8212395
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
O'Mara, Ann M
Project Start
2009-04-01
Project End
2014-01-31
Budget Start
2012-02-01
Budget End
2013-01-31
Support Year
4
Fiscal Year
2012
Total Cost
$293,520
Indirect Cost
$92,245
Name
Virginia Commonwealth University
Department
None
Type
Schools of Nursing
DUNS #
105300446
City
Richmond
State
VA
Country
United States
Zip Code
23298
Lyon, Debra; Kelly, Debra; Walter, Jeanne et al. (2015) Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus 4:369
Lyon, Debra; McCain, Nancy; Elswick, R K et al. (2014) Biobehavioral examination of fatigue across populations: report from a P30 Center of Excellence. Nurs Outlook 62:322-31
E Lyon, Debra; Mohanraj, Lathika; Kelly, Debra Lynch et al. (2014) Health Promoting Life-Style Behaviors and Systemic Inflamma-tion in African American and Caucasian Women Prior to Chemo-therapy for Breast Cancer. Health Promot Perspect 4:18-26
Kinser, Patricia A; Lyon, Debra E (2014) A conceptual framework of stress vulnerability, depression, and health outcomes in women: potential uses in research on complementary therapies for depression. Brain Behav 4:665-74
Lyon, Debra; Walter, Jeanne; Munro, Cindy L et al. (2011) Challenges in interpreting cytokine biomarkers in biobehavioral research: a breast cancer exemplar. Biol Res Nurs 13:25-31
Rattican, Debra; Kelly, Debra L; Filler, Kristin A et al. (2010) Back pain caused by a solitary plasmacytoma of bone. Clin J Oncol Nurs 14:149-52
Lyon, Debra E; Schubert, Christine; Taylor, Ann Gill (2010) Pilot study of cranial stimulation for symptom management in breast cancer. Oncol Nurs Forum 37:476-83