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Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
Sponsor: University of Oklahoma
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.
Official title: Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2023-12-01
Completion Date
2027-09
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Stephenson Cancer Center- Tulsa
Tulsa, Oklahoma, United States