Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Varenicline

Criteria

• Eligible patients will have a new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis

• Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization

• Have smoked daily or nearly every day in the previous 6 months up to the date of surgical consult AND have smoked at least one puff in the previous 7 days

• Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation Ladder

• Within the 30 days before registration, no use of: 1) any pharmacologic treatment for smoking cessation, including bupropion or nicotine replacement therapy; 2) any nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in any formal behavioral treatment program for tobacco dependence as determined by patient report

• No allergies to and not currently using varenicline

• No suicidal thoughts as indicated by a positive (1+) response to the PHQ9

• No active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)

• Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only

• A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

• No unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia

• No history of seizures

• No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease

• Not currently on renal dialysis or has a history of significant renal impairment

• No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:

• If male, drinking > 14 alcoholic beverages per week for past 1 month

• If female, drinking > 7 alcoholic beverages per week for past 1 month

• Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine (MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid diethylamide [LSD]) at any time during the past 1 month

• Use of marijuana on a weekly basis for the past 1 month

• Patients must be able to complete study questionnaires in English

• No other household member or relative participating in the study

• No known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence

• Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated creatinine clearance (CrCl) value