Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PARASYM neuromodulation device, PARASYM neuromodulation device.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Lymphoma. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
Overview
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.
Detailed description
Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) [Time frame: 2 weeks]
Secondary outcome measures (2)
- Effects of LLTS on autonomic tone [Time frame: 2 weeks]
- Effects of LLTS on oxidative stress [Time frame: 2 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Device feasibility
Study locations
United States · 2 centers
- Stephenson Cancer Center — Oklahoma City
- Stephenson Cancer Center- Tulsa — Tulsa
Identifiers
NCT: NCT05921253 · OU-SCC-NCAN