Breast Cancer, Lymphoma
Conditions
Keywords
Stimulation Device, Vagus Nerve Stimulator
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPARASYM neuromodulation device
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.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients (\>18 years) who have received anthracycline-based therapy for breast cancer or lymphoma within the last 30 days * A least 1 of following additional criteria: * previous chest radiation . Age\>50 * type 2 diabetes mellitus * hypertension * current smoking * obesity (BMI ≥ 30) * previous myocardial infarction * established atherosclerotic heart disease or significant valve disease. chronic kidney disease
Exclusion criteria
* Atrial paced rhythm * History of seizure currently on treatment * History of vasovagal syncope * End stage liver or kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of LLTS on autonomic tone | 2 weeks | 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. |
| Effects of LLTS on oxidative stress | 2 weeks | 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. |
Countries
United States
Contacts
CONTACTSCC IIT Office
CONTACTIngrid Block
PRINCIPAL_INVESTIGATORTarun W. Dasari, MD, MPH
University of Oklahoma
Outcome results
None listed