Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients with Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy with or without Chemotherapy

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients who are not smoking by self-report (journal and smoking cessation form completed at each visit) and confirmed biochemically (successful quitters) at 12 months post-radiation therapy (RT)/chemotherapy and radiation therapy (CRT) and compare proportions between the two study arms.

SECONDARY OBJECTIVES:

I. To compare the proportion of patients who are not smoking by self-report (journal and smoking cessation form completed at each visit) and confirmed biochemically at 6 months post-RT/CRT between the two study arms.

II. Among patients who quit smoking at time of diagnosis or anytime during treatment, determine and compare between two study arms the proportion of patients who experience smoking relapse at 12 months post-RT/CRT proportion of patients who are smoking at 12 months) by self-report (journal and smoking cessation form completed at each visit) and biochemical testing.

III. Among patients who quit smoking at time of diagnosis or anytime during treatment, determine and compare between two study arms the total number of smoking relapses for each patient and per each arm (per smoking journal and smoking cessation form completed at time of clinic visits).

IV. Among patients who quit smoking at time of diagnosis or anytime during treatment, determine and compare between two study arms the total number of days of smoking within the 12 months post-treatment for each patient and per each arm (based on smoking journal and smoking cessation form completed at time of clinic visit).

V. To compare the maximum degree of mucositis and mucositis-related pain assessed during radiation treatment and the following two weeks post-treatment between the two study arms.

VI. Determine the impact of study treatment on anxiety, depression and HNC symptoms/quality of life (QOL) at different time points (mid-treatment, the end of treatment and 3mo, 6mo and 12 mo post-treatment) and compare between two study arms.

VII. Collect descriptive data assessing smoking status among caregivers and corresponding data concerning whether smoking relapse occurs in our patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive bupropion hydrochloride orally (PO) for 3 days and then twice daily (BID) for up to 1 year post RT/CRT.

ARM B: Patients receive smoking cessation treatment tailored to individual smokers based on preference, smoking history, and contra-indications. Patients are given the choice of one of the National Comprehensive Cancer Network (NCCN)-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily on days 1-3 and then BID for 12 weeks or combination of nicotine patch and acute nicotine replacement therapy (NRT) for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Treatment with varenicline or NRT can be extended up to 6 months to 1 year as needed.

After completion of study, patients are followed up for 30 days.