Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
27. januar 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
- Legemiddel: High Intensity Counseling + Long Acting NRT + PRN NRT
- Legemiddel: High Intensity Counseling + bupropion + PRN NRT
- Legemiddel: High Intensity Counseling + varenicline + PRN NRT
- Legemiddel: High Intensity Counseling + Long Acting NRT
- Legemiddel: High Intensity Counseling + bupropion
- Legemiddel: High Intensity Counseling + varenicline
- Legemiddel: Low Intensity Counseling + Long Acting NRT + PRN NRT
- Legemiddel: Low Intensity Counseling + bupropion + PRN NRT
- Legemiddel: Low Intensity Counseling + varenicline + PRN NRT
- Legemiddel: Low Intensity Counseling + Long Acting NRT
- Legemiddel: Low Intensity Counseling + bupropion
- Legemiddel: Low Intensity Counseling + varenicline
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
93
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Kentucky
-
Ashland, Kentucky, Forente stater, 41101
- King's Daughters Medical Center
-
Elizabethtown, Kentucky, Forente stater, 42701
- Hardin Memorial Health Cancer Care Center
-
Hazard, Kentucky, Forente stater, 41701
- Kentucky Cancer Clinic
-
Hazard, Kentucky, Forente stater, 41701
- ARH Cancer Center
-
Lexington, Kentucky, Forente stater, 40536
- University of Kentucky, Markey Cancer Center
-
Lexington, Kentucky, Forente stater, 40502
- Lexington Veterans Affair Medical Center
-
Louisville, Kentucky, Forente stater, 40202
- University of Louisville, James Graham Brown Cancer Center
-
Morehead, Kentucky, Forente stater, 40351
- St. Claire Regional Medical Center
-
Owensboro, Kentucky, Forente stater, 42303
- Owensboro Health
-
-
West Virginia
-
Huntington, West Virginia, Forente stater, 25702
- St. Mary's Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: High Intensity Counseling + Long Acting NRT + PRN NRT
|
High Intensity Counseling + Long Acting NRT + PRN NRT
|
|
Eksperimentell: High Intensity Counseling + bupropion + PRN NRT
|
High Intensity Counseling + bupropion + PRN NRT
|
|
Eksperimentell: High Intensity Counseling + varenicline + PRN NRT
|
High Intensity Counseling + varenicline + PRN NRT
|
|
Eksperimentell: High Intensity Counseling + Long Acting NRT
|
High Intensity Counseling + Long Acting NRT
|
|
Eksperimentell: High Intensity Counseling + bupropion
|
High Intensity Counseling + bupropion
|
|
Eksperimentell: High Intensity Counseling + varenicline
|
High Intensity Counseling + varenicline
|
|
Eksperimentell: Low Intensity Counseling + Long Acting NRT + PRN NRT
|
Low Intensity Counseling + Long Acting NRT + PRN NRT
|
|
Eksperimentell: Low Intensity Counseling + bupropion + PRN NRT
|
Low Intensity Counseling + bupropion + PRN NRT
|
|
Eksperimentell: Low Intensity Counseling + varenicline + PRN NRT
|
Low Intensity Counseling + varenicline + PRN NRT
|
|
Eksperimentell: Low Intensity Counseling + Long Acting NRT
|
Low Intensity Counseling + Long Acting NRT
|
|
Eksperimentell: Low Intensity Counseling + bupropion
|
Low Intensity Counseling + bupropion
|
|
Eksperimentell: Low Intensity Counseling + varenicline
|
Low Intensity Counseling + varenicline
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cigarette use
Tidsramme: 8 weeks
|
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
|
8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joseph Valentino, M.D., University of Kentucky
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. juli 2014
Primær fullføring (Faktiske)
15. mai 2019
Studiet fullført (Faktiske)
15. mai 2019
Datoer for studieregistrering
Først innsendt
27. januar 2014
Først innsendt som oppfylte QC-kriteriene
27. januar 2014
Først lagt ut (Anslag)
29. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer i hode og nakke
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhemmere
- Psykotropiske stoffer
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhemmere
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, andre generasjon
- Cytokrom P-450 CYP2D6-hemmere
- Dopaminopptakshemmere
- Bupropion
- Vareniklin
Andre studie-ID-numre
- MCC-13-MULTI-13-KCTN-1301
- KCTN-1301 (Annen identifikator: Markey Cancer Center)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .