RECRUITING

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

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Conditions

Breast CancerLymphomaStimulation DeviceVagus Nerve Stimulator

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)

Quick Facts

Study Start:2023-12-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05921253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. * previous chest radiation,
  3. * type 2 diabetes mellitus,
  4. * hypertension,
  5. * current smoking,
  6. * obesity (BMI ≥ 30),
  7. * previous myocardial infarction or
  8. * established atherosclerotic heart disease.
  1. 1. atrial paced rhythm,
  2. 2. history of seizure currently on treatment,
  3. 3. history of vasovagal syncope,
  4. 4. end stage liver or kidney disease.

Contacts and Locations

Study Contact

SCC IIT Office
CONTACT
4052718777
SCC-IIT-Office@ouhsc.edu
Ingrid Block
CONTACT
4052718777
SCC-IIT-Office@ouhsc.edu

Principal Investigator

Tarun W. Dasari, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Tarun W. Dasari, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Stimulation Device
  • Vagus Nerve Stimulator

Additional Relevant MeSH Terms

  • Breast Cancer
  • Lymphoma