Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
Recruiting · NCT05921253 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Oklahoma
View the official record on ClinicalTrials.gov →Interventions studied
PARASYM neuromodulation device
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 1 US state.
- Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Stephenson Cancer Center- Tulsa - Tulsa, Oklahoma, United States