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

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedVarenicline and Placebo

Plus 1 other study approaches.

Who it may be forLung Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 27, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?374 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Surgery→Supportive or behavioral care→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

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.

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