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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
| University of Geneva, Switzerland | OTHER |
| University of Zurich | OTHER |
| State Hospital, St. Gallen |
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--> 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: ENDS and smoking cessation | Experimental |
| |
| Control group: Smoking cessation counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDS (vaporizer/e-cig) and smoking cessation counseling | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Reto Auer, Prof.Dr.med. | Berner Institut für Hausarztmedizin; Universität Bern | Study Director |
| Nancy Hopf, PD Dr. | Centre universitaire de médecine générale et santé publique, Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11036250 | Background | 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. | |
| 11147304 | Background | 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. |
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| OTHER_GOV |
| Swiss National Science Foundation | OTHER |
| Krebsforschung Schweiz, Bern, Switzerland | OTHER |
| Federal Office of Public Health, Switzerland | OTHER_GOV |
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Statisticians and laboratory personnel will be blinded to group allocation
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|
| Smoking cessation counseling | Other | 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. |
|
| University Clinic for General Internal Medicine, Bern University Hospital | Bern | 3010 | Switzerland |
| Département de médecine interne, Hôpitaux universitaires de Genève | Geneva | 1211 | Switzerland |
| Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich | Zurich | Switzerland |
| 27773997 | Background | 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. |
| 21044989 | Background | 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. |
| 18662802 | Background | 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. |
| 1951279 | Background | 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. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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