This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.
Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Enrollment
104
Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a preset position of one ear for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.
Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a different position of one ear compared to the "experimental arm" for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGStephenson Cancer Center- Tulsa
Tulsa, Oklahoma, United States
NOT_YET_RECRUITINGEffects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.
Time frame: 2 weeks
Effects of LLTS on autonomic tone
Measure change in autonomic tone by 15-minute Heart Rate Variability at baseline and follow up. (2 week) HRV has time and frequency domain numbers that are continuous variables from 0-100 and more.
Time frame: 2 weeks
Effects of LLTS on oxidative stress
Analyze markers of oxidative stress in serum collected from patients at baseline and at follow up. Serum will be analyzed for oxidative stress before and after use of the TENS device. Results are expressed in Units - continuous variable.
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.