Breast cancer is the second leading cause of cancer death in women in the United States. While now recommended for both localized and metastatic breast cancer, chemotherapy often results in distressing symptoms of fatigue, depression, anxiety, pain and sleep disturbances. Because of the limitations of conventional modalities for ameliorating these symptoms, there is a great need for the further development and testing of complementary therapies for symptom reduction. Cranial electrostimulation (CES) has demonstrated safety and efficacy for reliving depressive and anxiety symptoms, fatigue, sleep disturbances and pain in diverse clinical populations. This innovative pilot study proposes a 10-week trial of CES for reducing common, distressing symptoms in women receiving adjuvant chemotherapy for breast cancer. We propose a randomized, double-blinded study of the effects of CES compared to a sham group and treatment as usual (control group), on symptoms (depression and anxiety, fatigue, pain, sleep disturbances,) and biologic markers (NE, E, Serotonin, cortisol, IL-1, IL-6, and TNF-a). In addition to weekly symptom measures collected via Integrative Voice Technology (IVR), underlying physiologic mechanisms of these symptoms will be examined by collecting biologic measures in parallel to the symptom reports. The three-group design (active CES, sham CES, and usual care) will provide data for examining the placebo effect, if any. Since missing data is a common problem in clinical trials, we will pilot test the use of Interactive Voice Response (IVR) technology to collect and manage data. This study will provide the foundation for a larger RCT to examine the efficacy and physiologic effects of CES for women receiving adjunctive chemotherapy for breast cancer and will facilitate the entry of a new investigator into the field of cancer and complementary and alternative modalities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA106149-01
Application #
6604508
Study Section
Special Emphasis Panel (ZAT1-CP (03))
Program Officer
Mc Donald, Paige A
Project Start
2003-07-03
Project End
2004-06-30
Budget Start
2003-07-03
Budget End
2004-06-30
Support Year
1
Fiscal Year
2003
Total Cost
$228,000
Indirect Cost
Name
University of Virginia
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
Starkweather, Angela (2013) Psychologic and biologic factors associated with fatigue in patients with persistent radiculopathy. Pain Manag Nurs 14:41-9
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
Lyon, Debra E; McCain, Nancy L; Walter, Jeanne et al. (2008) Cytokine comparisons between women with breast cancer and women with a negative breast biopsy. Nurs Res 57:51-8