NCT05921253 Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
| NCT ID | NCT05921253 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Oklahoma |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2023-12-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Tarun W. Dasari, MD, MPH
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05921253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05921253 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05921253 currently recruiting?
Yes, NCT05921253 is actively recruiting participants. Contact the research team at SCC-IIT-Office@ouhsc.edu for enrollment information.
Where is the NCT05921253 trial being conducted?
This trial is being conducted at Oklahoma City, United States, Tulsa, United States.
Who is sponsoring the NCT05921253 clinical trial?
NCT05921253 is sponsored by University of Oklahoma. The principal investigator is Tarun W. Dasari, MD, MPH at University of Oklahoma. The trial plans to enroll 104 participants.
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