- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02048917
Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
27. januar 2020 opdateret af: Joseph Valentino, University of Kentucky
The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients.
This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Medicin: High Intensity Counseling + Long Acting NRT + PRN NRT
- Medicin: High Intensity Counseling + bupropion + PRN NRT
- Medicin: High Intensity Counseling + varenicline + PRN NRT
- Medicin: High Intensity Counseling + Long Acting NRT
- Medicin: High Intensity Counseling + bupropion
- Medicin: High Intensity Counseling + varenicline
- Medicin: Low Intensity Counseling + Long Acting NRT + PRN NRT
- Medicin: Low Intensity Counseling + bupropion + PRN NRT
- Medicin: Low Intensity Counseling + varenicline + PRN NRT
- Medicin: Low Intensity Counseling + Long Acting NRT
- Medicin: Low Intensity Counseling + bupropion
- Medicin: Low Intensity Counseling + varenicline
Detaljeret beskrivelse
Subjects enrolled in the study will be placed in one of twelve treatment arms.
Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
93
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kentucky
-
Ashland, Kentucky, Forenede Stater, 41101
- King's Daughters Medical Center
-
Elizabethtown, Kentucky, Forenede Stater, 42701
- Hardin Memorial Health Cancer Care Center
-
Hazard, Kentucky, Forenede Stater, 41701
- Kentucky Cancer Clinic
-
Hazard, Kentucky, Forenede Stater, 41701
- ARH Cancer Center
-
Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky, Markey Cancer Center
-
Lexington, Kentucky, Forenede Stater, 40502
- Lexington Veterans Affair Medical Center
-
Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville, James Graham Brown Cancer Center
-
Morehead, Kentucky, Forenede Stater, 40351
- St. Claire Regional Medical Center
-
Owensboro, Kentucky, Forenede Stater, 42303
- Owensboro Health
-
-
West Virginia
-
Huntington, West Virginia, Forenede Stater, 25702
- St. Mary's Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients must be ≥ 18 years of age.
Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
- Lung or Bronchus cancer or Head & Neck, cancers (all sites).
- Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
- Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation,cervical conization, LEEP].
- Having smoked at least 1 cigarette within 4 weeks of study enrollment.
- Having at least a 10-pack year history of cigarette smoking.
- Having smoked at least one cigarette within 1 month of cancer diagnosis.
- Life expectancy is greater than 1 year.
- Patient has an AUDIT score of < 10.
- Patient has ECOG Performance Status of <=2.
- Patients must have the ability to understand and the willingness to provide signed written informed consent document.
Exclusion Criteria:
- Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
- History of suicide attempt or preparation for attempt within the past 10 years.
C-SRSS Baseline/Screening:
- Patient response of "Yes" to any question except question 1.
- Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
- Hospitalized for psychiatric illness within the past two years.
- History of Bipolar disorder.
- Currently taking Bupropion for depression.
- Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
- History of eating disorder such as anorexia or bulimia.
- Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
- History of epilepsy or seizure disorder.
- Active severe kidney or liver disease.
- Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
- Patients within three months of a myocardial infarction.
- Patients with unstable angina or serious arrhythmia.
- Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
- Patient taking varenicline or bupropion within one month of study enrollment.
- Participation in any other investigational drug study within 4 weeks of study enrollment.
- Currently enrolled in other professional tobacco cessation therapeutic intervention.
- Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: High Intensity Counseling + Long Acting NRT + PRN NRT
|
High Intensity Counseling + Long Acting NRT + PRN NRT
|
Eksperimentel: High Intensity Counseling + bupropion + PRN NRT
|
High Intensity Counseling + bupropion + PRN NRT
|
Eksperimentel: High Intensity Counseling + varenicline + PRN NRT
|
High Intensity Counseling + varenicline + PRN NRT
|
Eksperimentel: High Intensity Counseling + Long Acting NRT
|
High Intensity Counseling + Long Acting NRT
|
Eksperimentel: High Intensity Counseling + bupropion
|
High Intensity Counseling + bupropion
|
Eksperimentel: High Intensity Counseling + varenicline
|
High Intensity Counseling + varenicline
|
Eksperimentel: Low Intensity Counseling + Long Acting NRT + PRN NRT
|
Low Intensity Counseling + Long Acting NRT + PRN NRT
|
Eksperimentel: Low Intensity Counseling + bupropion + PRN NRT
|
Low Intensity Counseling + bupropion + PRN NRT
|
Eksperimentel: Low Intensity Counseling + varenicline + PRN NRT
|
Low Intensity Counseling + varenicline + PRN NRT
|
Eksperimentel: Low Intensity Counseling + Long Acting NRT
|
Low Intensity Counseling + Long Acting NRT
|
Eksperimentel: Low Intensity Counseling + bupropion
|
Low Intensity Counseling + bupropion
|
Eksperimentel: Low Intensity Counseling + varenicline
|
Low Intensity Counseling + varenicline
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cigarette use
Tidsramme: 8 weeks
|
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
|
8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Valentino, M.D., University of Kentucky
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. juli 2014
Primær færdiggørelse (Faktiske)
15. maj 2019
Studieafslutning (Faktiske)
15. maj 2019
Datoer for studieregistrering
Først indsendt
27. januar 2014
Først indsendt, der opfyldte QC-kriterier
27. januar 2014
Først opslået (Skøn)
29. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer i hoved og hals
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhæmmere
- Psykotropiske stoffer
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhæmmere
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, anden generation
- Cytokrom P-450 CYP2D6-hæmmere
- Dopaminoptagelseshæmmere
- Bupropion
- Vareniclin
Andre undersøgelses-id-numre
- MCC-13-MULTI-13-KCTN-1301
- KCTN-1301 (Anden identifikator: Markey Cancer Center)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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