Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Not Applicable

Recruiting

• Conditions: Breast Cancer; Lymphoma
• Interventions: Device: PARASYM neuromodulation device

• Registration Number: NCT05921253
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-27
• Study Start: 2023-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Patients (>50 years) who have received anthracycline-based therapy (a cumulative dose of ≥ 200 mg/m2 Doxorubicin or bioequivalent dose of other anthracyclines) for breast cancer or lymphoma within the last 15-30 days

• A least 1 of following additional criteria:

  • previous chest radiation
  • type 2 diabetes mellitus
  • hypertension
  • current smoking
  • obesity (BMI ≥ 30)
  • previous myocardial infarction
  • established atherosclerotic heart disease.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self administration of Low Level Tragus Stimulation (LLTS; Placebo)	PARASYM neuromodulation device	PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.
Self administration of LLTS	PARASYM neuromodulation device	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.

Primary Outcome Measures

Name	Time	Method
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)	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 Outcome Measures

Name	Time	Method
Effects of LLTS on oxidative stress	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.
Effects of LLTS on autonomic tone	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.

Trial Locations

Locations (2)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Stephenson Cancer Center- Tulsa; 🇺🇸 Tulsa, Oklahoma, United States