Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
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.
Checked against the public recordLast updated Jul 27, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: Varenicline; Drug: Placebo; Other: Tobacco Cessation Counseling
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
* 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Fairbanks Memorial HospitalFairbanks, Alaska
- Kingman Regional Medical CenterKingman, Arizona
- Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
- PCR OncologyArroyo Grande, California
- Veterans Affairs Loma Linda Healthcare SystemLoma Linda, California
- Eisenhower Medical CenterRancho Mirage, California
- Saint Helena HospitalSt. Helena, California
- Rocky Mountain Cancer Centers-AuroraAurora, Colorado
- The Medical Center of AuroraAurora, Colorado
- University of Colorado HospitalAurora, Colorado
- Boulder Community HospitalBoulder, Colorado
- Rocky Mountain Cancer Centers-BoulderBoulder, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 27, 2022. Always confirm current availability with the study team.