title: 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.
abstract: OBJECTIVE
  Women with breast cancer may experience symptoms of depression, anxiety, pain, fatigue and sleep disturbances during chemotherapy. However, there are few modalities that address multiple, commonly occurring symptoms that may occur in individuals receiving cancer treatment. Cranial electrical stimulation (CES) is a treatment that is FDA cleared for depression, anxiety and insomnia. CES is applied via electrodes placed on the ear that deliver pulsed, low amplitude electrical current to the head.
  
  
  METHODS
  This phase III randomized, sham-controlled study aimed to examine the effects of cranial microcurrent stimulation on symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Patients were randomly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinicaltrials.gov, NCT00902330.
  
  
  RESULTS
  The sample included N = 167 women with early-stage breast cancer. Symptom severity of depression, anxiety, and fatigue and sleep disturbances were generally mild to moderate. Levels of pain were low. Anxiety was highest prior to the initial chemotherapy and decreased over time. The primary outcome assessment (symptoms of depression, anxiety, fatigue, pain, sleep disturbances) revealed no statistically significant differences between the two groups, actual CES vs. sham.
  
  
  CONCLUSIONS
  In this study, women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range. Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer, further symptom management modalities should be evaluated to mitigate symptoms of depression, anxiety, fatigue, pain and sleep disturbances over the course of chemotherapy.
authors.affiliation: Kirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Lyon
authors.affiliation: Kirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Kelly
authors.affiliation: Virginia Commonwealth University School of Nursing, Richmond, Virginia USA.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Walter
authors.affiliation: Massey Cancer Center, School of Medicine, Virginia Commonwealth University, Richmond, Virginia USA.
authors.forename: Harry
authors.initials: H
authors.lastname: Bear
authors.affiliation: Virginia Commonwealth University School of Nursing, Richmond, Virginia USA.
authors.forename: Leroy
authors.initials: L
authors.lastname: Thacker
authors.affiliation: Virginia Commonwealth University School of Nursing, Richmond, Virginia USA.
authors.forename: Ronald K
authors.initials: RK
authors.lastname: Elswick