Cranial electrotherapy stimulation for the management of depression, anxiety, sleep disturbance, and pain in patients with advanced cancer: A preliminary study.

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229 Background: Cranial Electrotherapy Stimulation (CES) is a safe modulation of brain activity for treating depression, anxiety, insomnia, and pain. However, there are no published studies in patients with advanced cancer (ACP).The aim of the study was to determine the feasibility and preliminary efficacy of a 4-week CES intervention on depression, anxiety, sleep disturbance, and pain scores. Concurrent salivary biomarker studies were conducted. Methods: In this one group open label pre- and post-intervention study with a 4-week CES intervention, ACP’s with one or more of four moderate intensity (≥3/10) ESAS symptoms (depression, anxiety, sleep disturbance, and pain) were eligible. Adherence (0-100%), satisfaction rates(0-10), and safety were assessed. ESAS, HADS, PSQI, BPI, and salivary levels (cortisol, alpha amylase, CRP, and IL-1 beta and IL-6) were assessed from baseline to week 4. Results: 33/38(87%) completed the CES. Median (IQR) adherence for days with 60 min CES use and satisfaction scores were 93(89-100)% and 10(9-10) respectively. CES use was safe (no grade 3 or higher adverse events). HADS anxiety (p < 0.001), HADS depression (p = 0.024), ESAS anxiety (p = 0.001), depression (p = 0.025), BPI pain (p = 0.013), PSQI daytime dysfunction (p = 0.002), and Medication use (p = 0.006) scores improved after 4 week CES treatment. There was no significant change in the salivary cortisol, alpha-amylase, CRP, IL-1β, and IL-6 levels after 4 weeks of CES. Conclusions: In this preliminary study we found that the use of cranial Electrotherapy stimulation (CES) was safe and feasible in ACP. The use of CES was associated with significant improvement of depression, anxiety, pain, and sleep scores. These findings support further studies of CES in ACP for symptom control.