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

University of Kentucky10 sites in 1 country93 target enrollmentJuly 22, 2014

ConditionsLung Cancer Head and Neck Cancer

Overview

Phase: Phase 1
Intervention: High Intensity Counseling + bupropion
Conditions: Lung Cancer
Sponsor: University of Kentucky
Enrollment: 93
Locations: 10
Primary Endpoint: Cigarette use
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

July 22, 2014

End Date

May 15, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Kentucky

Responsible Party

Principal Investigator

Joseph Valentino

Study Chair

University of Kentucky

Eligibility Criteria

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 \<

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
•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.