Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
NCT ID: NCT05921253
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
104 participants
INTERVENTIONAL
2023-12-01
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
TRIPLE
Study Groups
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Self administration of Low Level Tragus Stimulation (LLTS; Placebo)
PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.
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.
Self administration of LLTS
PARASYM neuromodulation device will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of seizure currently on treatment
* History of vasovagal syncope
* End stage liver or kidney disease
18 Years
99 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Tarun W. Dasari, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Stephenson Cancer Center- Tulsa
Tulsa, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OU-SCC-NCAN
Identifier Type: -
Identifier Source: org_study_id
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