|Grant Number:||7R21CA106149-02 Interpret this number|
|Primary Investigator:||Lyon, Debra|
|Organization:||Virginia Commonwealth University|
|Project Title:||Cranial Stimulation for Chemo Symptoms in Breast Cancer|
DESCRIPTION (provided by applicant): 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.