NCT04244773: ESTxENDS

ESTxENDS Trial: MN Substudy - Micronuclei in Buccal Epithelium, a Surrogate Measure of Future Cancer Risk, Induced by Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)

Completed NA Last updated 15 November 2023

What this trial tests

NA trial testing ENDS (vaporizer/e-cig) and smoking cessation counseling in Smoking Cessation in 1,246 participants. Completed in 31 August 2023.

Timeline

18 November 2019

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	University of Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,246
Start date	18 November 2019
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	5 locations across Switzerland

Drugs / interventions tested

• ENDS (vaporizer/e-cig) and smoking cessation counseling
• Smoking cessation counseling

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Micronuclei — all drugs for Micronuclei →

Sponsor

University of Bern

Who can join

18 and older, any sex, with Smoking Cessation or Micronuclei. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

--\> This is a substudy of the main ESTxENDS trial (NCT03589989). Micronuclei in buccal epithelial outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.

Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking.

The micronucleus cytologic assay test was originally developed to screen for drug toxicity in bone marrow samples from mammals. The technique identifies micronuclei on smears obtained by oral cavity exfoliation and indicate genomic instability. Buccal MNs may predict cancer risk for the upper aerodigestive tract. The HUman MicroNucleus project on eXfoLiated buccal cells (HUMNXL) found MN counts gradually increased during the progression from normal mucosal to precancerous lesions to carcinoma. MN assessment discriminates between exposure to tobacco smoke in smokers and in non-smokers, and has been tested on a small number of ENDS users.

For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measures of MN frequency will test the potential effect of ENDS use on cancer-related outcomes, in particular incident of mouth-, lung- and kidney- cancers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.