This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02856581.
PRIMARY OBJECTIVES:
I. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.
SECONDARY OBJECTIVES:
I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention (varenicline) and control group (placebo).
II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.
III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse (“Was It Worth It”) each treatment (intervention versus [vs] control groups).
IV. To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups.
V. To compare treatment adherence between the intervention and control groups.
VI. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only.
TERTIARY OBJECTIVES:
I. To evaluate the predictive role of the nicotinic receptor gene cluster CHRNA5-CHRNA3-CHRNB4) and CYP2A6 genotypes in smoking cessation among lung cancer patients undergoing surgery.
II. To evaluate the potential moderating effect of these cessation-relevant genotypes on smoking cessation treatment between the intervention and control groups.
OUTLINE: Patients are randomized to 1 of 2 groups.
INTERVENTION GROUP: Patients receive varenicline orally (PO) once daily (QD) on days 1-3 and twice daily (BID) on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity.
CONTROL GROUP: Patients receive placebo PO QD on day 1-3 and PO BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients in both groups complete behavioral intervention consisting of no smoking message from surgical team member and how to use National Cancer Institute (NCI) quitline at surgical consult.
After completion of study treatment, patients are followed up at 18 and 24 weeks.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorIvana Tallerico Croghan
