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Neuromodulation for Chemotherapy-Related Cardiovascular Risks (OU-SCC-NCAN Trial)

Q: Does my profile align with the requirements for this medical investigation?

<p>Patients with a diagnosis of <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, aged between 50 and 99 years old, can apply to participate in this study. 104 individuals are required by the research team.</p>

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,819 Total Patients Enrolled

3 Trials studying Lymphoma

317 Patients Enrolled for Lymphoma

Tarun W. Dasari, MD, MPHPrincipal InvestigatorUniversity of Oklahoma

Media Library

PARASYM TENS unit (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05921253 — N/A

Lymphoma Research Study Groups: Self administration of LLTS, Self administration of Low Level Tragus Stimulation (LLTS; Placebo)

Lymphoma Clinical Trial 2023: PARASYM TENS unit Highlights & Side Effects. Trial Name: NCT05921253 — N/A

PARASYM TENS unit (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05921253 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

2023. "Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05921253.