S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery

Study Overview
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Brief Summary
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RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion. PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage I or II non-small cell lung cancer who are current smokers. Compare the predictors of smoking cessation success in patients treated with these regimens. Determine the relationship between smoking cessation and standard outcome measures (e.g., second malignancies, survival, and symptom status) in patients treated with these regimens. Compare the effect of these treatment regimens on emotional functioning in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to gender, prior neoadjuvant or concurrent adjuvant chemotherapy and/or radiotherapy (yes vs no), and time since prior surgery (less than 6 months vs 6 to 12 months vs more than 12 months). Patients are randomized to 1 of 2 arms. All patients receive behavioral intervention comprising smoking cessation advice and education on day 1. Patients quit smoking on day 8. Patients then receive a nicotine transdermal patch once daily on days 8-77. Arm I: Patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77. Arm II: Patients receive oral placebo as in arm I. Patients are followed at 3, 6, and 12 months and then annually for 10 years. PROJECTED ACCRUAL: A total of 468 patients (234 [117 men and 117 women] per arm) will be accrued for this study within 3 years.

Official Title
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Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: smoking cessation intervention
* Drug: bupropion hydrochloride
* Drug: nicotine
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease Must be free of recurrent or progressive disease Current smoker defined as: Smoked at least 100 cigarettes in entire life AND Currently smoking some days or every day Must establish a quit date that falls within 30 days after registration, but 7 days after physician advice and start of bupropion or placebo therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Not within an immediate post-infarction period No uncontrolled arrhythmias No unstable angina No uncontrolled hypertension (unstable blood pressure, diastolic pressure 90 mm Hg or greater) Other: Must be able to read, speak, and understand English Must be willing to allow testing of saliva for cotinine levels No history of seizures No history of eating disorders No known drug-drug interactions between nicotine patch and/or bupropion and patient's current or planned medications including chemotherapy and antiemetics No concurrent psychiatric diagnosis that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent adjuvant chemotherapy allowed Endocrine therapy: No concurrent systemic steroids Radiotherapy: Concurrent adjuvant radiotherapy allowed Surgery: See Disease Characteristics Recovered from prior surgery Other: Prior neoadjuvant therapy allowed At least 14 days since prior medications containing bupropion (e.g., Wellbutrin or Wellbutrin SR) No other concurrent medications that contain bupropion (e.g., Wellbutrin or Wellbutrin SR) No concurrent monoamine oxidase inhibitors No concurrent medications that lower seizure threshold (e.g., antipsychotics, antidepressants, or theophylline) No other concurrent nicotine replacement therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Behavioral Intervention + Placebo<br>Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo. | Behavioral: smoking cessation intervention<br>* Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy<br>Drug: nicotine<br>* 21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.<br>* Other names: Nicoderm CQ;Procedure: psychosocial assessment and care<br>* The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).<br>|
| Active Comparator: Behavioral Intervention + Bupropion<br>Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride . | Behavioral: smoking cessation intervention<br>* Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy<br>Drug: bupropion hydrochloride<br>* 150 mg/day on Days 1-3, 300 mg/day on Day 4-77<br>* Other names: Zyban;Drug: nicotine<br>* 21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.<br>* Other names: Nicoderm CQ;Procedure: psychosocial assessment and care<br>* The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect on 12 month quit rates of adding an anti-depressant versus placebo in a double blind to an intervention and nicotine replacement in complete resected Stage I and II non-small cell lung cancer patients who are current smokers |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess predictors of successful cessation in male and female patients. |  | 12 months | 
| To explore the relationship between smoking cessation and standard outcome measures. |  | 12 months | 
| To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer