Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.

Study Design Phase II therapeutic clinical trial.

Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)

Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).

Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.

Revised Enrollment Number: Effective with Amendment 2, Expand targeted enrollment from 96 to 126 due to higher than expected drop-out/censoring rate in order to evaluate the primary endpoint

Inclusion criteria

• newly diagnosed or recurrent tobacco related malignancy
• smoked at least 1 cigarette within 4 weeks of study enrollment
• 10-pack year history of cigarette smoking
• smoked at least 1 cigarette within 1 month of cancer diagnosis
• life expectancy greater than 1 year

Exclusion criteria

• allergy to buproprion, varenicline and transdermal medicine
• history of suicide attempt
• hospitalized for psychiatric illness within past 2 years
• history of active or uncontrolled eating disorder
• uncontrolled epilepsy or seizure disorder
• pregnant or lactating
• within 3 months of myocardial infarction
• unstable angina
• uncontrolled hypertension
• serious arrhythmia
• history of taking varenicline or buproprion within one month of enrollment
• concurrent enrollment in tobacco cessation therapy