Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Lung Cancer
• Intervention / Treatment: Drug: High Intensity Counseling + Long Acting NRT + PRN NRT; Drug: High Intensity Counseling + bupropion + PRN NRT; Drug: High Intensity Counseling + varenicline + PRN NRT; Drug: High Intensity Counseling + Long Acting NRT; Drug: High Intensity Counseling + bupropion; Drug: High Intensity Counseling + varenicline; Drug: Low Intensity Counseling + Long Acting NRT + PRN NRT; Drug: Low Intensity Counseling + bupropion + PRN NRT; Drug: Low Intensity Counseling + varenicline + PRN NRT; Drug: Low Intensity Counseling + Long Acting NRT; Drug: Low Intensity Counseling + bupropion; Drug: Low Intensity Counseling + varenicline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • King's Daughters Medical Center
    • Elizabethtown, Kentucky, United States, 42701
      • Hardin Memorial Health Cancer Care Center
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
    • Hazard, Kentucky, United States, 41701
      • ARH Cancer Center
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky, Markey Cancer Center
    • Lexington, Kentucky, United States, 40502
      • Lexington Veterans Affair Medical Center
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, James Graham Brown Cancer Center
    • Morehead, Kentucky, United States, 40351
      • St. Claire Regional Medical Center
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Health
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Lung or Bronchus cancer or Head & Neck, cancers (all sites).
  2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
  3. 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:

  1. Patient response of "Yes" to any question except question 1.
  2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Counseling + Long Acting NRT + PRN NRT	Drug: High Intensity Counseling + Long Acting NRT + PRN NRT; High Intensity Counseling + Long Acting NRT + PRN NRT
Experimental: High Intensity Counseling + bupropion + PRN NRT	Drug: High Intensity Counseling + bupropion + PRN NRT; High Intensity Counseling + bupropion + PRN NRT
Experimental: High Intensity Counseling + varenicline + PRN NRT	Drug: High Intensity Counseling + varenicline + PRN NRT; High Intensity Counseling + varenicline + PRN NRT
Experimental: High Intensity Counseling + Long Acting NRT	Drug: High Intensity Counseling + Long Acting NRT; High Intensity Counseling + Long Acting NRT
Experimental: High Intensity Counseling + bupropion	Drug: High Intensity Counseling + bupropion; High Intensity Counseling + bupropion
Experimental: High Intensity Counseling + varenicline	Drug: High Intensity Counseling + varenicline; High Intensity Counseling + varenicline
Experimental: Low Intensity Counseling + Long Acting NRT + PRN NRT	Drug: Low Intensity Counseling + Long Acting NRT + PRN NRT; Low Intensity Counseling + Long Acting NRT + PRN NRT
Experimental: Low Intensity Counseling + bupropion + PRN NRT	Drug: Low Intensity Counseling + bupropion + PRN NRT; Low Intensity Counseling + bupropion + PRN NRT
Experimental: Low Intensity Counseling + varenicline + PRN NRT	Drug: Low Intensity Counseling + varenicline + PRN NRT; Low Intensity Counseling + varenicline + PRN NRT
Experimental: Low Intensity Counseling + Long Acting NRT	Drug: Low Intensity Counseling + Long Acting NRT; Low Intensity Counseling + Long Acting NRT
Experimental: Low Intensity Counseling + bupropion	Drug: Low Intensity Counseling + bupropion; Low Intensity Counseling + bupropion
Experimental: Low Intensity Counseling + varenicline	Drug: Low Intensity Counseling + varenicline; Low Intensity Counseling + varenicline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette use	Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.	8 weeks

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: Kentucky Lung Cancer Research Program
• Investigators: Principal Investigator: Joseph Valentino, M.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Counseling; Smoking; Bupropion; Tobacco; Nicotine; Varenicline; Cessation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion; Varenicline
• Other Study ID Numbers: MCC-13-MULTI-13-KCTN-1301; KCTN-1301 (Other Identifier: Markey Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No