Lung Cancer
Conditions
Keywords
non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer
Brief summary
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
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.
Interventions
BEHAVIORALsmoking cessation intervention
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
150 mg/day on Days 1-3, 300 mg/day on Day 4-77
DRUGnicotine
21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.
PROCEDUREpsychosocial assessment and care
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).
Sponsors
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| To assess the relationship among metabolic polymorphism genes associated with lung cancer susceptibility in smokers who are lung cancer patients. | 12 months |
| To examine the relationship of nicotine susceptibility markers to 1 month quit rate, gender and pharmacologic (nicotine replacement therapy and either placebo or bupropion. | 12 months |
| To explore the relationship of nicotine dependence genetic markers to 12 month quit rates by way of the dopamine D2 receptor gene (DRD2). | 12 months |
Countries
Puerto Rico, United States
Outcome results
None listed