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Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)

Who can join

Ages 18 to 99 · All sexes

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

About the 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.

What is being tested

• PARASYM neuromodulation device (device)
• PARASYM neuromodulation device (device)

Sponsor: University of Oklahoma · Participants: 104 · Started: Dec 1, 2023

Contact the study team

• SCC IIT Office · Phone: 4052718777
• Ingrid Block · Phone: 4052718777

Official record on ClinicalTrials.gov — NCT05921253

Locations in the U.S.

Conditions

• Breast Cancer
• Lymphoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.