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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self administration of Low Level Tragus Stimulation (LLTS; Placebo) | Placebo Comparator | PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days. |
|
| Self administration of LLTS | Experimental | PARASYM neuromodulation device will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARASYM neuromodulation device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Effects of LLTS on oxidative stress |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SCC IIT Office | Contact | 4052718777 | SCC-IIT-Office@ouhsc.edu | |
| Ingrid Block | Contact | 4052718777 | SCC-IIT-Office@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tarun W. Dasari, MD, MPH | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
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|
| PARASYM neuromodulation device | 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 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. |
|
|
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. |
| 2 weeks |
| Stephenson Cancer Center- Tulsa | Not yet recruiting | Tulsa | Oklahoma | 74104 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |