Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Breast Cancer Clinical Trial

— OU-SCC-NCAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921253
• Other study ID #: OU-SCC-NCAN
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: SCC IIT Office
• Phone: 4052718777
• Email: SCC-IIT-Office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Patients (>50 years) with breast cancer or lymphoma, who have received anthracycline-based therapy (a cumulative dose of = 200 mg/m2 Doxorubicin or bioequivalent dose of other anthracyclines) and/or HER2 antagonists within the last 60-90 days and have >= 1 of following additional criteria:

• previous chest radiation,

• type 2 diabetes mellitus,

• hypertension,

• current smoking,

• obesity (BMI = 30),

• previous myocardial infarction or

• established atherosclerotic heart disease.

Exclusion Criteria:

1. atrial paced rhythm,

2. history of seizure currently on treatment,

3. history of vasovagal syncope,

4. end stage liver or kidney disease.

Related Conditions & MeSH terms

• Breast Cancer
• Lymphoma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effects of LLTS on autonomic tone	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 weeks
Secondary	Effects of LLTS on oxidative stress	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.	2 weeks