A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
时间窗: 10 weeks
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.
次要结局
- One- and two-year distant metastases-free survival rates(2 years)
- One- and two-year local-regional control rates(2 years)
- One- and two-year progression-free survival rates(2 years)
- ≥ Grade 3 acute and late adverse event(2 years)