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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT04244773

Studienbeginn:
November 2019

Letztes Update:
27.10.2020

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Bern

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

Studienleiter

Reto Auer, Prof.Dr.med.
Study Director
Berner Institut für Hausarztmedizin; Universität Bern
Nancy Hopf, PD Dr.
Principal Investigator
Centre universitaire de médecine générale et santé publique, Lausanne

Kontakt

Studienlocations (3 von 5)

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ivan Berlin, Prof.Dr.med
E-Mail: ivan.berlin@aphp.fr
» Ansprechpartner anzeigen
University Clinic for General Internal Medicine, Bern University Hospital
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Nicolas Rodondi, Prof.Dr.med
E-Mail: Nicolas.Rodondi@insel.ch
» Ansprechpartner anzeigen
Département de médecine interne, Hôpitaux universitaires de Genève
1211 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Jean-Paul Humair, PD Dr.med.
E-Mail: Jean-Paul.Humair@hcuge.ch
» Ansprechpartner anzeigen
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
Saint-Gall
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Martin Brutsche, Prof.Dr.med.
E-Mail: Martin.Brutsche@kssg.ch
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Frequency of buccal micronuclei_1 (Time Frame - Baseline):
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.

2. Frequency of buccal micronuclei_2 (Time Frame - 6 months post quit date):
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.

3. Frequency of buccal micronuclei_3 (Time Frame - 12 months post quit date):
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.

4. Frequency of buccal micronuclei_4 (Time Frame - 24 months post quit date):
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.

Secondary outcome:

1. Change of frequency of buccal micronuclei (Time Frame - Change from baseline to 6,12, 24 months post quit date):
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.

Studien-Arme

  • Experimental: Intervention group: ENDS and smoking cessation
  • Active Comparator: Control group: Smoking cessation counseling

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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