NCT05921253

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for early_phase_1 breast-cancer

Timeline
16mo left

Started Dec 2023

Typical duration for early_phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Dec 2023Sep 2027

First Submitted

Initial submission to the registry

June 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

June 12, 2023

Last Update Submit

January 22, 2026

Conditions

Breast CancerLymphoma

Keywords

Stimulation DeviceVagus Nerve Stimulator

Outcome Measures

Primary Outcomes (1)

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

    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.

    2 weeks

Secondary Outcomes (2)

  • Effects of LLTS on autonomic tone

    2 weeks

  • Effects of LLTS on oxidative stress

    2 weeks

Study Arms (2)

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

PLACEBO COMPARATOR

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

Device: PARASYM neuromodulation device

Self administration of LLTS

EXPERIMENTAL

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.

Device: PARASYM neuromodulation device

Interventions

PARASYM neuromodulation deviceDEVICE

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.

Also known as: Experimental
Self administration of LLTS

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Atrial paced rhythm
  • History of seizure currently on treatment
  • History of vasovagal syncope
  • End stage liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Stephenson Cancer Center- Tulsa

Tulsa, Oklahoma, 74104, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tarun W. Dasari, MD, MPH

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SCC IIT Office

CONTACT

4052718777SCC-IIT-Office@ouhsc.edu

Ingrid Block

CONTACT

4052718777SCC-IIT-Office@ouhsc.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 27, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)