Trial Information

Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

OBJECTIVES:

Primary

- To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES
over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in
women with stage I-IIIA breast cancer receiving adjuvant chemotherapy.

Secondary

- To explore the relationships among selected markers of inflammation (e.g., tumor
necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein),
symptoms, and quality of life.

- To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances,
and pain form a cluster.

- To examine the effects of CES on quality of life.

OUTLINE: Patients are stratified according to chemotherapy schedule (every 2 weeks for 8
courses vs every 3 weeks for 6 courses). Patients are randomized to 1 of 2 treatment arms.

- Arm I (cranial microcurrent electrical stimulation [CES]): Patients receive a CES unit
(Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic
electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1
hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50%
duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use
their CES unit once daily in weeks 1-18.

- Arm II (sham CES): Patients receive a CES unit as in arm I, but the ear-lobe electrodes
do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.

Patients complete symptom questionnaires (e.g., the Hospital Anxiety and Depression Scale,
the Brief Pain Inventory Short-Form, the Brief Fatigue Inventory, and the General Sleep
Disturbance Scale) weekly in weeks 1-18. Patients also complete a quality-of-life
questionnaire in weeks 1, 7, and 18.

Blood samples are collected in weeks 1, 7, and 18 and analyzed for cytokines (e.g., tumor
necrosis factor alpha, interleukin-6, and interleukin-1β) and C-reactive protein.