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Device
Neuromodulation for Chemotherapy-Related Cardiovascular Risks (OU-SCC-NCAN Trial)
N/A
Recruiting
Led By Tarun W. Dasari, MD, MPH
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
OU-SCC-NCAN Trial Summary
This trial tests if low-level nerve stim improves heart rate, function & reduces inflammation markers in the blood.
Who is the study for?
This trial is for individuals with breast cancer or lymphoma who have had chest radiation, type 2 diabetes, high blood pressure, are current smokers, obese (BMI ≥ 30), or have a history of heart attack or heart disease. It's not suitable for those who don't meet these conditions.Check my eligibility
What is being tested?
The study tests if a PARASYM neuromodulation device can improve heart function and variability as well as reduce inflammation markers in the blood when used by patients undergoing cardiotoxic chemotherapy.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation, changes in blood pressure or heart rate, headache, hoarseness, and coughing due to vagus nerve stimulation.
OU-SCC-NCAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
Secondary outcome measures
Effects of LLTS on autonomic tone
Effects of LLTS on oxidative stress
OU-SCC-NCAN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Self administration of LLTSExperimental Treatment1 Intervention
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.
Group II: Self administration of Low Level Tragus Stimulation (LLTS; Placebo)Placebo Group1 Intervention
PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,669 Total Patients Enrolled
3 Trials studying Lymphoma
317 Patients Enrolled for Lymphoma
Tarun W. Dasari, MD, MPHPrincipal InvestigatorUniversity of Oklahoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 50, had specific cancer treatments, and have at least one health condition like diabetes or heart disease.I have end-stage liver or kidney disease.I have a history of fainting due to sudden drops in heart rate and blood pressure.I am currently being treated for seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Self administration of LLTS
- Group 2: Self administration of Low Level Tragus Stimulation (LLTS; Placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project open to participants of advanced age?
"The eligibility requirements for this trial necessitate that any participant needs to be between 50 and 99 years of age."
Answered by AI
Does my profile align with the requirements for this medical investigation?
"Patients with a diagnosis of breast cancer, aged between 50 and 99 years old, can apply to participate in this study. 104 individuals are required by the research team."
Answered by AI
Is this clinical trial currently accepting new participants?
"Clinicaltrials.gov data reveals that this study, initially posted on July 1st 2023 and last modified on June 26th 2023 is no longer recruiting patients; however, 3119 other trials are actively enrolling at the present time."
Answered by AI
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