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

Alliance for Clinical Trials in Oncology

Status and phase: Terminated; Phase 3

Conditions: Lung Carcinoma

Treatments: Other: Tobacco Cessation Counseling; Drug: Varenicline; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02856581

A211401

NCI-2016-00438 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Intervention group (varenicline and behavioral intervention)

Experimental group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Drug: Varenicline

Control group (placebo and behavioral intervention)

Placebo Comparator group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Drug: Placebo