Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention group (varenicline and behavioral intervention)
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
  • Drug: Varenicline
    Given PO
  • Other: Tobacco Cessation Counseling
    Complete counseling session
Placebo Comparator
Control group (placebo and behavioral intervention)
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
  • Drug: Placebo
    Given PO
  • Other: Tobacco Cessation Counseling
    Complete counseling session

Recruiting Locations

More Details

NCT ID
NCT02856581
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Ivana Croghan, PhD
507-284-7313
croghan.ivana@mayo.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.