ACTIVE_NOT_RECRUITING

Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

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 is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.

Official Title

Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects

Quick Facts

Study Start:2022-11-22
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05239793

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:21 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mild to moderate COPD
  2. * Smokes a popular brand of cigarette
  3. * Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use
  4. * Ability to read, write and understand English
  5. * Ability to provide informed consent and attend study visits
  1. * History of active, chronic drug abuse or alcohol abuse problems
  2. * Actively changing smoking behavior
  3. * Unwilling or unable to provide blood samples
  4. * Pregnant, planning to become pregnant, or nursing
  5. * Use of tobacco products other than cigarettes in the past 30 days
  6. * Recent history (\< 6 months) of myocardial infarction (MI)
  7. * Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide
  8. * Hospitalization for heart failure (NY Heart Association III or IV) within the past year
  9. * Uncontrolled hypertension
  10. * Known allergy to vegetable glycerin and propylene glycol
  11. * History of seizures or medications to prevent seizures

Contacts and Locations

Principal Investigator

Rebecca Bascom, MD
PRINCIPAL_INVESTIGATOR
Penn State Health Hershey Medical Center
Raghu Sinha, PhD
PRINCIPAL_INVESTIGATOR
Penn State Health Hershey Medical Center

Study Locations (Sites)

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Rebecca Bascom, MD, PRINCIPAL_INVESTIGATOR, Penn State Health Hershey Medical Center
  • Raghu Sinha, PhD, PRINCIPAL_INVESTIGATOR, Penn State Health Hershey Medical Center

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 Date2022-11-22
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-11-22
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease