RecruitingEarly Phase 1NCT05921253

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)


Sponsor

University of Oklahoma

Enrollment

104 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a nerve-stimulation treatment called low-level vagus nerve stimulation (or a similar non-invasive technique) can protect the heart from damage caused by anthracycline chemotherapy — a class of powerful chemotherapy drugs used for breast cancer and lymphoma that can cause heart problems over time. The treatment aims to activate the body's own nervous system to reduce inflammation and heart stress during chemotherapy. **You may be eligible if:** - You are over 18 years old - You have received anthracycline-based chemotherapy for breast cancer or lymphoma within the past 30 days - You have at least one additional heart disease risk factor, such as: age over 50, type 2 diabetes, high blood pressure, current smoking, obesity, previous heart attack, established heart disease or significant valve disease, or chronic kidney disease - You also had previous chest radiation **You may NOT be eligible if:** - You have a paced heart rhythm (an artificial pacemaker controlling your heart rate) - You have a history of seizures that are currently being treated - You have a history of fainting episodes (vasovagal syncope) - You have end-stage liver or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPARASYM 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.

DEVICEPARASYM 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.


Locations(2)

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Stephenson Cancer Center- Tulsa

Tulsa, Oklahoma, United States

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NCT05921253


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