Improving heart function in cancer patients using vagus nerve stimulation
Official title: Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
Run by University of Oklahoma · NCT05921253 · Data updated 2026-11-12
This study is testing whether a small device that stimulates the vagus nerve can help improve heart function in cancer patients who have recently received chemotherapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Oklahoma City, Oklahoma and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | September 2027 |
| Study ends | September 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT05921253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients over 50 years old who have received anthracycline-based therapy for breast cancer or lymphoma within the last 15-30 days and have additional cardiovascular risk factors.
✕Probably not a fit
Patients with atrial paced rhythm, history of seizures, or end-stage liver or kidney disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of low-level vagus nerve stimulation on heart function and inflammation markers in patients who have recently undergone anthracycline-based chemotherapy for breast cancer or lymphoma. Participants will use a handheld device to deliver stimulation to one ear for one hour daily over a 14-day period. The goal is to assess improvements in heart rate variability and chemical markers in the blood, which may indicate better heart health. This approach aims to mitigate cardiovascular risks associated with certain cancer treatments.
Why it matters
Potential benefit: If successful, this could lead to improved heart health and reduced cardiovascular risks for cancer patients undergoing specific chemotherapy treatments.
How similar studies have gone: While the approach of vagus nerve stimulation is gaining interest, this specific application in the context of cardiotoxic chemotherapy is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States Recruiting -
Stephenson Cancer Center- Tulsa
Tulsa, Oklahoma, United States Recruiting
Study contacts
- Principal investigator: Tarun W. Dasari, MD, MPH — University of Oklahoma
- Study coordinator: SCC IIT Office
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 4052718777
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.