Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
2 other identifiers
interventional
93
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lung-cancer
Started Jul 2014
Typical duration for phase_1 lung-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedJanuary 29, 2020
January 1, 2020
4.8 years
January 27, 2014
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cigarette use
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
8 weeks
Study Arms (12)
High Intensity Counseling + Long Acting NRT + PRN NRT
EXPERIMENTALHigh Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
EXPERIMENTALHigh Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
EXPERIMENTALHigh Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT
EXPERIMENTALHigh Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion
EXPERIMENTALHigh Intensity Counseling + bupropion
High Intensity Counseling + varenicline
EXPERIMENTALHigh Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT
EXPERIMENTALLow Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
EXPERIMENTALLow Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
EXPERIMENTALLow Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT
EXPERIMENTALLow Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion
EXPERIMENTALLow Intensity Counseling + bupropion
Low Intensity Counseling + varenicline
EXPERIMENTALLow Intensity Counseling + varenicline
Interventions
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion
High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion
Low Intensity Counseling + varenicline
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kentuckylead
- Kentucky Lung Cancer Research Programcollaborator
Study Sites (10)
King's Daughters Medical Center
Ashland, Kentucky, 41101, United States
Hardin Memorial Health Cancer Care Center
Elizabethtown, Kentucky, 42701, United States
ARH Cancer Center
Hazard, Kentucky, 41701, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Lexington Veterans Affair Medical Center
Lexington, Kentucky, 40502, United States
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536, United States
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
St. Claire Regional Medical Center
Morehead, Kentucky, 40351, United States
Owensboro Health
Owensboro, Kentucky, 42303, United States
St. Mary's Medical Center
Huntington, West Virginia, 25702, United States
Related Publications (1)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Valentino, M.D.
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Chair
Study Record Dates
First Submitted
January 27, 2014
First Posted
January 29, 2014
Study Start
July 22, 2014
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
January 29, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share