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)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    1172
  • sponsor
    University of Bern
Updated on 25 January 2021
cancer
tobacco smoke
nicotine replacement
cigarette smoke

Summary

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 this trial, 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.

Details
Condition Smoking Cessation, Micronuclei, smoking cessation therapy
Treatment Smoking Cessation Counseling, ENDS (vaporizer/e-cig) and smoking cessation counseling
Clinical Study IdentifierNCT04244773
SponsorUniversity of Bern
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed Consent as documented by signature
Persons aged 18 or older
Currently smoking 5 or more cigarettes a day for at least 12 months
Willing to try to quit smoking within the next 3 months
Persons providing a valid phone number, a valid email address and/or a valid postal address

Exclusion Criteria

Known hypersensitivity or allergy to contents of the e-liquid Participation in
another study with investigational drug within the 30 days preceding the
baseline visit and during the present study where interactions are to be
expected
Women who are pregnant or breast feeding
Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
Persons having used ENDS regularly in the 3 months preceding the baseline visit
Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
Persons who cannot attend the 6- month follow-up visit for any reason
Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures
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