Trial Information

Summary: A study to test the effects of the Alpha-Stim device on common symptoms associated with chemotherapy (pain, fatigue, depression/anxiety, insomnia).

What is the purpose of this study?
The purpose of this study is to test the effects of the Alpha-Stim device on common symptoms associated with chemotherapy (pain, fatigue, depression/anxiety, insomnia). Women with breast cancer may use some form of therapy in addition to their regular medical treatment and there is little published data on how microcurrent cranial electrotherapy works in helping with symptoms related to chemotherapy. This study will attempt to determine if using this device will produce greater benefits than an inactive device, and/or treatment as usual for the same amount of time and whether women receiving chemotherapy can use the device successfully. You will be randomly assigned to one of the three groups.

What is a Cranial Stimulation Device?
The Alpha-Stim Cranial Electrical Stimulator is a FDA-approved device using tiny electrical currents similar to those found naturally in the body that may reduce common symptoms such as pain, fatigue, sleep disturbances and anxiety/depressive symptoms in women with breast cancer receiving chemotherapy. Similar devices have been used in over 4,000 individuals with a variety of health problems.

What will I be asked to do?
If you choose to participate, we will ask you to do the following:

• Complete a one time self-report form and four short questionnaires
• Allow additional blood to be drawn along with your routine pre-chemotherapy blood draws
• At home, the CES is to be used for 60 minutes per day at approximately the same time each day, one week prior to and one week following your chemotherapy
• Collect salivary samples
• Make a weekly phone call to rate your symptoms

You should not participate in this study if you:

• Currently use antidepressants (for example Zoloft, Prozac, or Paxil), anticonvulsants, psychiatric medicines or botanical products such as St. John's wort or Kava with antidepressant properties
• Are pregnant and/or have an implanted pacemaker/defibrillator

Potential risks are minimal. There is a $400 payment for participation and completion of this study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.