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RecruitingEarly Phase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether gentle stimulation of the vagus nerve can improve heart function, changes in heart rate, and blood signs of inflammation. It is for adults who recently received anthracycline chemotherapy for breast cancer or lymphoma and have at least one other heart risk factor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18 and have received anthracycline chemotherapy for breast cancer or lymphoma in the past 30 days.
  • You must also have at least one of the following risk factors:
  • Past radiation treatment to the chest, or age over 50.
  • Type 2 diabetes or high blood pressure.
  • Currently smoking, or obesity (a body mass index, or BMI, of 30 or higher).
  • A past heart attack.
  • Heart disease from clogged arteries, or a major problem with a heart valve.
  • Long-term kidney disease.

Who can't join

  • A pacemaker controls the rhythm in your heart’s upper chambers.
  • You have had seizures and are currently being treated for them.
  • You have a history of vasovagal fainting, caused by a sudden drop in heart rate or blood pressure.
  • You have end-stage liver or kidney disease, meaning the organ is failing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

OK