Smoking Cessation Strategies in Community Cancer Programs for Lung and Head and Neck Cancer Patients
Conditions
Lung Cancer - Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Smoking, Cessation, Bupropion, Varenicline, Nicotine, Counseling, Tobacco
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: High Intensity Counseling + Long Acting NRT + PRN NRT Type: Drug
Name: High Intensity Counseling + bupropion + PRN NRT Type: Drug
Name: High Intensity Counseling + varenicline + PRN NRT Type: Drug
Name: High Intensity Counseling + Long Acting NRT Type: Drug
Name: High Intensity Counseling + bupropion Type: Drug
Name: High Intensity Counseling + varenicline Type: Drug
Name: Low Intensity Counseling + Long Acting NRT + PRN NRT Type: Drug
Name: Low Intensity Counseling + bupropion + PRN NRT Type: Drug
Name: Low Intensity Counseling + varenicline + PRN NRT Type: Drug
Name: Low Intensity Counseling + Long Acting NRT Type: Drug
Name: Low Intensity Counseling + bupropion Type: Drug
Name: Low Intensity Counseling + varenicline Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients must be ≥ 18 years of age.

- Patient with newly diagnosed or recurrent, histologic diagnosis of Lung cancer or Head & Neck cancer (categories: Oral Cavity, Pharynx and Larynx only).

- 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.

- Therapy planned is of curative intent.

- 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.

- 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.
Locations
King's Daughters Medical Center
Ashland, Kentucky, United States
Status: Recruiting
Contact: Sherry Davis, RN - 606-408-1636 - Sherry.davis@kdmc.kdhs.us
Hardin Memorial Health Cancer Care Center
Elizabethtown, Kentucky, United States
Status: Recruiting
Contact: Diane Drobny, RN - 270-234-3250 - ddrobny@hmh.net
ARH Cancer Center
Hazard, Kentucky, United States
Status: Recruiting
Contact: Vicky Boggs, RN - 606-487-7907 - viboggs@arh.org
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Status: Recruiting
Contact: Janie Chapman, RN - 606-439-2239 - jchapman@kycancerclinic.com
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Status: Recruiting
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States
Status: Recruiting
Contact: Jennifer Schoenbachler, RN - 502-217-5229 - jennifer.schoenbachler@louisville.edu
St. Claire Regional Medical Center
Morehead, Kentucky, United States
Status: Recruiting
Contact: Mary Horsley, RN - 606-783-6476 - MAHorsley@st-claire.org
Start Date
July 2014
Completion Date
February 2017
Sponsors
University of Kentucky
Source
University of Kentucky
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page