Cranial Stimulation Tried for Managing Side Effects of Chemotherapy in Breast Cancer

Division of Cancer Prevention

Women being treated with chemotherapy for breast cancer often experience multiple side effects includ­ing fatigue, mild to moderate levels of anxiety and depressive symptoms, sleep disturbances, and pain. These side effects often occur together. “Conventional medications are not terribly effective for these symptoms,” noted Debra Lyon, R.N., Ph.D. “Furthermore, many women with breast cancer don’t want to take any extra medication, unless they absolutely have to.”

With funding from NCI*, Dr. Lyon, an associate professor and chair of the Department of Family and Community Health Nursing in the School of Nursing at Virginia Commonwealth University is exploring a new, drug-free approach to relieving these symptoms. The approach – known as cranial microcurrent electrical stimulation (CES) – delivers a low-level electrical current to the head using a portable electronic device known as an Alpha-Stim, which is roughly the size of a BlackBerry device. “It was designed to be something that busy people can use in their homes,” explained Dr. Lyon. In her study, women can carry the device in a pocket while they are walking around the house, doing chores, relaxing with a book, or watching TV.

Scientists do not yet understand the exact mechanism of how electrical stimulation can affect the brain, Dr. Lyon said, “but there is evidence that CES may initiate a physiological change by inducing changes in brain activity consistent with a relaxed state (as noted by EEG patterns), or by stimulating neurotransmitter or endorphin release. These physiological changes are associated with lower levels of pain and depressive and anxiety symptoms, and may also have positive effects on related symptoms of fatigue and sleep disturbances.”

Starting in April 2009, Dr. Lyon and her colleagues are recruiting a total of 166 women, who are receiv­ing chemotherapy for early-stage breast cancer, to participate in the five-year study. Half of the women will be treated with CES for one hour a day. The other half will be given a “sham” device that appears identical to the Alpha-Stim unit but does not deliver any current through the electrodes. Neither the patients nor the researchers will know which device a patient has. The electrical current used in CES is so mild that patients cannot feel it, Dr. Lyon said.

In a previous pilot study, also funded by NCI, Dr. Lyon found that women were not able to tell whether they had the actual or the sham electronic device. “Any standardized, portable, symptom-management therapy that we can use in breast cancer, and potentially in other cancers, to give patients a way to self-manage their common symptoms has potential importance for enhancing their quality of life, and also perhaps leading to their feeling like they can complete their treatment while continuing to manage multiple other daily concerns,” said Dr. Lyon.

The cost of an Alpha-Stim device, which is available by prescription in the United States and runs on a 9-volt battery, ranges from $300 to $600. “While the up-front cost may be a little higher than a one-month supply of medication,” noted Dr. Lyon, “over time it should be pretty cost-effective.”

As part of the current study Dr. Lyon will also investigate whether CES affects the levels of several proteins in the body that play a role in inflammation, and whether there is a link between the levels of these proteins and the symptoms being studied. Dr. Lyon has found that women with breast cancer have high levels of these proteins, and previous findings by others suggest a possible link between depression and elevated levels of inflammatory proteins. “What we’re thinking in this study, and in the field called psychoneuroimmunology, is that if individuals are feeling stress relief, that not only can it lead to symptom improvement, but it can also lead to stopping the biological chain reaction that promotes or enhances the level of stress,” Dr. Lyon said.