Recruiting
Early Phase 1

Vagus Nerve Stimulation

Sponsor:

University of Oklahoma

Code:

NCT05921253

Conditions

Breast Cancer

Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PARASYM neuromodulation device

PARASYM neuromodulation device

Study Details

Brief 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.

Conditions

Breast Cancer

Lymphoma

Study ID

NCT05921253

Start date

Dec 1, 2023

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

placebo comparator: Self administration of Low Level Tragus Stimulation (LLTS; Placebo)

PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.

experimental: Self administration of LLTS

PARASYM neuromodulation device will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.

Interventions

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.

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 measure

  • Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

SCC IIT Office

4052718777SCC-IIT-Office@ouhsc.edu

Ingrid Block

4052718777SCC-IIT-Office@ouhsc.edu

Locations

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

SCC IIT Office

405-271-8777SCC-IIT-Office@ouhsc.edu

Principal Investigator:

Tarun W. Dasari, MD, MPH

More Information

Sponsor

University of Oklahoma

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Stimulation Device
  • Vagus Nerve Stimulator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-01-26.