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)
University of Oklahoma
104 participants
Dec 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria4
- Atrial paced rhythm
- History of seizure currently on treatment
- History of vasovagal syncope
- End stage liver or kidney disease
Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05921253