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Trial Title:
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
NCT ID:
NCT05921253
Condition:
Breast Cancer
Lymphoma
Conditions: Keywords:
Stimulation Device
Vagus Nerve Stimulator
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, randomized, sham controlled, double-blinded study of low-level tragus
stimulation vs. sham treatment.
Primary purpose:
Other
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
PARASYM neuromodulation device
Description:
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.
Arm group label:
Self administration of LLTS
Other name:
Experimental
Intervention type:
Device
Intervention name:
PARASYM neuromodulation device
Description:
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.
Arm group label:
Self administration of Low Level Tragus Stimulation (LLTS; Placebo)
Other name:
Placebo
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
SCC IIT Office
Phone:
405-271-8777
Email:
SCC-IIT-Office@ouhsc.edu
Investigator:
Last name:
Tarun W. Dasari, MD, MPH
Email:
Principal Investigator
Start date:
December 1, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
University of Oklahoma
Agency class:
Other
Source:
University of Oklahoma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921253
