NCT05921253EARLY_PHASE1Recruiting

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

University of Oklahoma

Start Date

12/1/2023

Completion Date

9/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DEVICE

PARASYM neuromodulation device

DEVICE

PARASYM neuromodulation device

Interested in This Trial?

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Conditions

Breast CancerLymphoma

Locations

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Stephenson Cancer Center- Tulsa

Tulsa, Oklahoma 74104

United States