Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy

Study Overview
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Brief Summary
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To propose a feasibility study of introducing a smoking cessation program in head and neck cancer patients with planned radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation.

Detailed Description
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Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute and late complications but also poor clinical tumor response, poor local control, and poor overall survival. However, smoking cessation has not been included into the standard intervention in treating head and neck cancer patients in Taiwan. We propose a prospective study of introducing a smoking cessation program in head and neck cancer patients receiving radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation. The primary outcome is to test the feasibility of the smoking cessation intervention, and the secondary outcome is to test the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor response, patterns of relapse, and overall survival.

Official Title
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A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Behavioral: Smoking cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70 years Head and Neck Malignancy Stage I-IVB without distant metastasis Receiving five weeks or more of external beam radiotherapy Report smoking one or more cigarettes in the past 30 days or self-identify as a smoker KPS 70-100 Exclusion Criteria: Serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician A current diagnosis of major depressive episode or a history of psychosis, bipolar disorder, or seizure disorder Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refer for smoking cessation<br>Refer for smoking cessation | Behavioral: Smoking cessation<br>* Refer for smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less. | The primary outcome was to test the feasibility of introducing a smoking cessation program in head and neck cancer patients undergoing radiotherapy. Smoking cessation status will be formally assessed by patient report and by carbon monoxide (CO) breath test. The status of tobacco abstinence will be confirmed by carbon monoxide breath test concentrations of 3 ppm or less. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ Grade 3 acute and late adverse event | The secondary outcomes were to test the efficacy of smoking cessation during radiotherapy on acute and late radiation therapy toxicities, tumor response, patterns of relapse, and overall survival. | 2 years | 
| One- and two-year local-regional control rates | All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group. | 2 years | 
| One- and two-year distant metastases-free survival rates | All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group. | 2 years | 
| One- and two-year progression-free survival rates | All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy,Smoking pattern,head and neck cancer