Smoking cessation intervention for patients with head and neck cancer: A prospective randomized controlled trial

Aims: To evaluate the effectiveness of a brief smoking cessation intervention in head and neck cancer patients (HNCP). Study design: A prospective randomized controlled trial that randomly assigns participants in two groups: a usual care group (UCG), and a standardized intervention group (SIG). Material and methods: Patients with a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) and who are active smokers were prospectively approached by one of 4 trained Ear-nose-throat (ENT) residents. Participants were randomized into a UCG, and a SIG consisting of a brief perioperative smoking cessation intervention based on National Institute of Health (NIH) "5A's" model along with an informative motivational document and nicotine patch therapy (NPT) offered for 8 weeks in gradually decreasing doses. Objective: The evaluation of abstinence at 3, 6 and 12 months after enrollment. Results: 56 subjects were randomized into the UCG (N = 29, 52%), and the SIG (N = 27, 48%). The overall smoking cessation rates were not statistically different between the two groups; we observed at 3 months cessation rates of 57.1% vs. 57.7% (p = 0.96); at 6 months, 42.9% vs. 24% (p = 0.148); and at 12 months, 33.3% vs. 20.8% (p = 0.318), for the UCG and the SIG respectively. Conclusion: This study failed to show the effectiveness of a combined brief smoking cessation approach led by and ENT resident in HNSCC patients. A multifaceted approach addressing different pharmacological treatments, factors contributing to smoking maintenance, mainly alcohol dependence and mood disturbances and dealing with relapse risks through close face-to-face or phone call follow-ups may have better outcomes and should be evaluated in upcoming trials.