Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy (OU-SCC-NCAN)

University of Oklahoma (OU)

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Cancer; Lymphoma

Treatments: Device: PARASYM neuromodulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT05921253

OU-SCC-NCAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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

Treatment:

Device: PARASYM neuromodulation device

Device: PARASYM neuromodulation device

Self administration of LLTS

Experimental group

Description:

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.

Treatment:

Device: PARASYM neuromodulation device

Device: PARASYM neuromodulation device