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Neuromodulation for Heart Risks After Chemotherapy

This study is exploring if a device called PARASYM neuromodulation can help improve heart function in people who have received certain chemotherapy treatments for breast cancer or lymphoma. Chemotherapy can sometimes affect the heart, and this study aims to see if low-level vagus nerve stimulation (a gentle electrical pulse to a nerve in the ear) can help. You might be eligible if you are over 18, have received anthracycline-based chemotherapy within the last 30 days, and have certain risk factors like previous chest radiation, diabetes, or high blood pressure. The main goal is to see if this stimulation improves a measure of heart function called global longitudinal strain (GLS) after two weeks. The study plans to enroll 104 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 104 participants.
What's involved
You would use a handheld electrical unit at home to deliver vagus nerve stimulation to one ear for one hour daily, for 14 days. You will also have tests to determine your heart function.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring heart function is at 2 weeks.

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NCT05921253

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Recruiting
EARLY_PHASE1Ages 18–99InterventionalDevice feasibility
University of Oklahoma
~104 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:PARASYM neuromodulation device

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
Measured over 2 weeks

Conditions

Breast Cancer
Lymphoma

Explore related trials

Breast CarcinomaLymphoma

Where it's being run

2 sites across 1 states
Oklahoma2

Study leadership

  • Tarun W. Dasari, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Who to contact

SCC IIT Office
[email protected]
4052718777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Atrial paced rhythm
History of seizure currently on treatment
History of vasovagal syncope
End stage liver or kidney disease

What this trial measures

  • 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.