Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05921253
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • PARASYM neuromodulation device — 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 — 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stephenson Cancer CenterOklahoma CityOklahoma73104
SCC IIT Office
[email protected]
405-271-8777
Tarun W. Dasari, MD, MPH (PRINCIPAL_INVESTIGATOR)
Stephenson Cancer Center- TulsaTulsaOklahoma74104
Laura K Brett, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oklahoma City, OK

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stephenson Cancer Center· Oklahoma City, OKStephenson Cancer Center- Tulsa· Tulsa, OK

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