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NCT Number: NCT05921253

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARASYM neuromodulation device

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.

Other names: Experimental

Primary outcomes

  1. Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)

    Time frame: 2 weeks

    An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.

Secondary outcomes

  1. Effects of LLTS on autonomic tone

    Time frame: 2 weeks

    Measure change in autonomic tone by 15-minute Heart Rate Variability at baseline and follow up. (2 week) HRV has time and frequency domain numbers that are continuous variables from 0-100 and more.

  2. Effects of LLTS on oxidative stress

    Time frame: 2 weeks

    Analyze markers of oxidative stress in serum collected from patients at baseline and at follow up. Serum will be analyzed for oxidative stress before and after use of the TENS device. Results are expressed in Units - continuous variable.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Block

CONTACT

[email protected]

4052718777

SCC IIT Office

CONTACT

[email protected]

4052718777

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: OU-SCC-NCAN

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 27, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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