Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)

Cigarette Smoking Clinical Trial

Official title:

Are Smokers Switching to Vaping at Lower Risk for Cancer?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03750825
• Other study ID #: HS-18-00744
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will address a growing public health concern, namely, the health risks or benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of early effects of relevance to cancer to determine the carcinogenic potential of e-cig use relative to cigarette smoking in oral epithelium, which is a target tissue for smoking-associated cancer. The study population will consist of one group of smokers who are interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to change their smoking habits (Grp 2), and one group of non-users who would like to maintain their nonsmoking non-vaping status (Grp 3); The total number of participants in this project is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants as the intervention progresses.

Description:

Electronic cigarettes (e-cig) are increasingly popular among adult smokers and adolescent never smokers. Chemical analyses of e-cig vapor and liquid have shown the presence of many of the same carcinogens as those found in cigarette smoke, albeit in generally lower concentrations. However, the carcinogenic potential of e-cig has not been investigated in e-cig users (otherwise known as 'vapers'). The investigators will investigate the cancer-causing potential of e-cig use as compared to cigarette smoking by quantifying molecular changes linked to risk of cancer in smokers who switch to e-cig use vs. those who maintain their smoking habits. Leveraging a source population for ongoing studies on e-cig, the investigators will recruit smokers who are interested in switching to e-cig use, and two control groups of non-vapers, including smokers and nonsmokers who do not intend to change their smoking and nonsmoking status, respectively (n = 50, each group). Smokers consenting to switch completely to e-cig will be assigned to a 3-month intervention with a standard e-cig with fully described product characteristics. Control groups will maintain their smoking/nonsmoking habits during the intervention. At weekly intervals, the investigators will verify participants' compliance through personal interviews, CO breath tests, cotinine quantification, and vaping/smoking topography measurements. The investigators will use a non-invasive brushing technique to collect oral cells from the inside of the cheeks of all participants at baseline and every 2 weeks, afterwards. The investigators will use an integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants as the intervention progresses.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 55 Years

Eligibility

Inclusion Criteria:

• Being male or female between the ages of 22-55;
• Being able to read and write in English and understand and give informed consent;
• Giving consent to strictly follow the study protocol throughout the study;
• Not planning to move, take an extended vacation, or undergo surgery during the study;
• Reporting smoking of > 5 manufactured cigarettes per day for at least 1 year (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only); and
• Presenting with an expired air CO measurement of > 7 parts per million (ppm) at baseline (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only).

Exclusion Criteria:

• Having oral infection/inflammation, gum disease, dental decay, immune system disorders, diabetes, respiratory diseases (e.g., asthma), or kidney diseases;
• Having any unstable or significant medical condition (e.g., symptomatic heart conditions) in the past 12 months ;
• Having body mass index < 18 kg/m2 or > 40 kg/m2
• Being pregnant or having a baby in the past 12 months;
• Having uncontrolled mental illness or substance abuse (e.g., alcoholism) or inpatient treatment for those conditions in the past 12 months;
• Having used recreational or illicit drugs in the past 3 months;
• Having used any medication known to induce/inhibit CYP450 2A6 enzyme;
• Having any known allergy to propylene glycol/vegetable glycerin (applicable participants who will undergo intervention with e-cig (Grp 1) only); and
• Having another member of household participating in the study.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Device:
• NIDA Standard Research E-cigarette (SREC)
Smokers will switch to NIDA Standard Research E-cigarette (SREC).

Locations

Country	Name	City	State
United States	University of Southern California, Health Sciences Campus	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic changes	Number and location of DNA damage	3 months
Primary	Epigenetic changes	Number of epigenetic marks	3 months
Secondary	Gene expression	Relative gene expression	Every 2 weeks for 3 months
Secondary	DNA methylation	Pattern and distribution of aberrant DNA methylation	Every 2 weeks for 3 months
Secondary	Histone modifications	Pattern and distribution of histone marks	Every 2 weeks for 3 months
Secondary	Mutation	Frequency and location of mutations	Every 2 weeks for 3 months