Cranial stimulation is a complementary medicine intervention that provides electrical stimulation to the brain. Cranial electrical stimulation studied in patients with cancer was delivered via a medical device that delivered a programmed level of electrical stimulation via electrodes attached to the earlobes with a low intensity delivered from a battery source. This intervention was studied in patients with cancer for its effect on fatigue and sleep/wake disturbance.
Effectiveness Not Established
Research Evidence Summaries
Lyon, D. E., Schubert, C., & Taylor, A. G. (2010). Pilot study of cranial stimulation for symptom management in breast cancer. Oncology Nursing Forum, 37, 476–483.doi: 10.1188/10.ONF.476-483
To determine whether cranial electrical stimulation (CES) is feasible for symptom management in patients with breast cancer receiving chemotherapy and to examine the outcomes for reducing the symptoms of fatigue, depression, anxiety, pain, and sleep disturbances in these patients.
Intervention Characteristics/Basic Study Process:
Symptom reports (on fatigue, depression, anxiety, pain, and sleep disturbances) were collected at baseline by a research associate and then weekly using an interactive voice response (IVR) phone system. Patients were trained on the use of the CES devices and were able to use them at a setting of 100 µA for up to sixty minutes per day. They began using the devices on the first day of their chemotherapy infusions. Patients receiving chemotherapy every two weeks used the CES device for a total of six weeks; those receiving chemotherapy every three weeks used them for a total of eight weeks. A follow-up interview was held after patients finished the protocol.
- The study included 34 women aged 18 years and older (mean = 48.3 years [standard deviation (SD) = 7.9 years]).
- All patients had breast cancer and were receiving chemotherapy.
Phase of Care and Clinical Applications:
Patients were undergoing the active treatment phase of care.
This was a prospective, double-blind, three-group, randomized, longitudinal pilot feasibility study.
- Hospital Anxiety and Depression Scale (HADS)
- Brief Pain Inventory (BPI)–short form
- Brief Fatigue Inventory (BFI)
General Sleep Disturbance Scale (GSDS)
Positive correlations existed between all symptoms, except pain and anxiety. Pain and fatigue symptoms were highly correlated with C-reactive protein.
CES appears to be a safe intervention during chemotherapy. This study showed that CES was a feasible and safe intervention during chemotherapy. It also showed positive correlations between several symptom management variables, but larger studies are needed to determine whether CES is effective for symptom management.
- Some data were missing due to the ineffectiveness of the IVR system.
- The study did not describe significant findings about this intervention on pain management in patients with cancer and would not be particularly valuable for the ONS Pain PEP project.
- The study had a small sample size, with less than 100 patients.
- No analysis of outcomes between groups was performed.
The study examined several symptoms seen in patients with breast cancer. Larger studies are needed to examine whether CES has a true effect on pain symptoms in patients with breast cancer.