Recruiting
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
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.
ClinicalTrials.gov IDNCT05921253
PhaseEARLY_PHASE1
Enrollment104
SponsorUniversity of Oklahoma
Age18 Years
SexALL
Conditions studied
Breast Cancer, Lymphoma
About this study
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.
Interventions
- Device: PARASYM 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.
- Device: PARASYM 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 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.
Primary outcomes
- Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) (2 weeks)
Eligibility information
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
Study locations
- Stephenson Cancer Center, Oklahoma City, Oklahoma 73104 United States
- Stephenson Cancer Center- Tulsa, Tulsa, Oklahoma 74104 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.