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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04244773
Other study ID # 2017-02332i
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 18, 2019
Est. completion date August 31, 2023

Study information

Verified date November 2023
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

--> 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.


Recruitment information / eligibility

Status Completed
Enrollment 1246
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ENDS (vaporizer/e-cig) and smoking cessation counseling
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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
Smoking cessation counseling
Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Locations

Country Name City State
Switzerland University Clinic for General Internal Medicine, Bern University Hospital Bern
Switzerland Département de médecine interne, Hôpitaux universitaires de Genève Geneva
Switzerland Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne Lausanne Vaud
Switzerland Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen Saint-Gall
Switzerland Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich Zürich

Sponsors (8)

Lead Sponsor Collaborator
University of Bern Federal Office of Public Health, Switzerland, Krebsforschung Schweiz, Bern, Switzerland, State Hospital, St. Gallen, Swiss National Science Foundation, University of Geneva, Switzerland, University of Lausanne, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

Bloching M, Hofmann A, Lautenschlager C, Berghaus A, Grummt T. Exfoliative cytology of normal buccal mucosa to predict the relative risk of cancer in the upper aerodigestive tract using the MN-assay. Oral Oncol. 2000 Nov;36(6):550-5. doi: 10.1016/s1368-8375(00)00051-8. — View Citation

Casartelli G, Bonatti S, De Ferrari M, Scala M, Mereu P, Margarino G, Abbondandolo A. Micronucleus frequencies in exfoliated buccal cells in normal mucosa, precancerous lesions and squamous cell carcinoma. Anal Quant Cytol Histol. 2000 Dec;22(6):486-92. — View Citation

El-Setouhy M, Loffredo CA, Radwan G, Abdel Rahman R, Mahfouz E, Israel E, Mohamed MK, Ayyad SB. Genotoxic effects of waterpipe smoking on the buccal mucosa cells. Mutat Res. 2008 Aug-Sep;655(1-2):36-40. doi: 10.1016/j.mrgentox.2008.06.014. — View Citation

Franco T, Trapasso S, Puzzo L, Allegra E. Electronic Cigarette: Role in the Primary Prevention of Oral Cavity Cancer. Clin Med Insights Ear Nose Throat. 2016 Oct 17;9:7-12. doi: 10.4137/CMENT.S40364. eCollection 2016. — View Citation

Nersesyan A, Muradyan R, Kundi M, Knasmueller S. Impact of smoking on the frequencies of micronuclei and other nuclear abnormalities in exfoliated oral cells: a comparative study with different cigarette types. Mutagenesis. 2011 Mar;26(2):295-301. doi: 10.1093/mutage/geq092. Epub 2010 Nov 2. — View Citation

Tolbert PE, Shy CM, Allen JW. Micronuclei and other nuclear anomalies in buccal smears: a field test in snuff users. Am J Epidemiol. 1991 Oct 15;134(8):840-50. doi: 10.1093/oxfordjournals.aje.a116159. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of buccal micronuclei_1 MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant. Baseline
Primary Frequency of buccal micronuclei_2 MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant. 6 months post quit date
Primary Frequency of buccal micronuclei_3 MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant. 12 months post quit date
Primary Frequency of buccal micronuclei_4 MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant. 24 months post quit date
Secondary Change of frequency of buccal micronuclei MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant. Change from baseline to 6,12, 24 months post quit date
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