Improving heart function in cancer patients using vagus nerve stimulation
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
EARLY_PHASE1 · University of Oklahoma · NCT05921253
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_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Oklahoma City, Oklahoma and 1 other locations) |
| Trial ID | NCT05921253 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with atrial paced rhythm, history of seizures, or end-stage liver or kidney disease may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Oklahoma City, Oklahoma and 1 other locations
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
- Stephenson Cancer Center- Tulsa — Tulsa, Oklahoma, United States (NOT_YET_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Lymphoma, Stimulation Device, Vagus Nerve Stimulator