Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Proportion of patients who are not smoking
研究概览
简要总结
This pilot randomized clinical trial studies how well bupropion hydrochloride works compared with patient's choice for quitting smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may help patients quit smoking by enhancing central nervous system neurotransmitters noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride is more effective than patient's choice in helping quit smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients who are not smoking (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 at 6 months post-RT/CRT between the two study arms.
II. Among patients who quit smoking, determine the proportion of patients who experience smoking relapse at 12 months post-RT/CRT and compare between the two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed squamous cell carcinoma of the nasopharynx, oropharynx, larynx, hypopharynx, oral cavity
- •Patients must be scheduled to receive RT or CRT as definitive treatment or surgery with planned adjuvant RT or CRT treatment post-surgery per surgeon or Head and Neck Cancer (HNC) Tumor Board decision
- •Patients should receive their definitive treatment at Wake Forest University (WFU) Cancer Center or at Medical University of South Carolina (MUSC) Cancer Center
- •Patients must be active smokers (defined as smoking any cigarette, cigar or pipe in the last 30 days)
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •Patients who receive RT or CRT with palliative intent and have a prognosis of less than one year survival
- •Patients who chew tobacco and patients who are not smoking but are exposed to second hand smoking are excluded from this study
- •Patients currently using a smoking cessation treatment
- •Other known drug use/abuse
- •Patients with documented contraindications for bupropion (bupropion hydrochloride), including: bulimia nervosa, anorexia nervosa; use of monoamine oxidase inhibitors in the past two weeks; documented seizure disorders or predisposition to seizure (ie stroke, brain metastases); abrupt withdrawal from alcohol, benzodiazepines, or other sedatives; closed-angle glaucoma
- •Patients with diagnosis of major depression or any other psychiatric disorders
- •Documented history of allergic reactions attributed to compounds of similar chemical or biologic composition to buproprion
- •Any other significant acute or chronic diseases that in the investigator's opinion would exclude the subject from the trial
研究组 & 干预措施
Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
干预措施: Bupropion Hydrochloride (Drug)
Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
干预措施: Quality-of-Life Assessment (Other)
Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
干预措施: Questionnaire Administration (Other)
Arm B (varenicline, NRT)
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 NCCN-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute 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.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B (varenicline, NRT)
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 NCCN-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute 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.
干预措施: Nicotine Replacement (Drug)
Arm B (varenicline, NRT)
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 NCCN-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute 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.
干预措施: Questionnaire Administration (Other)
Arm B (varenicline, NRT)
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 NCCN-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute 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.
干预措施: Varenicline (Drug)
结局指标
主要结局
Proportion of patients who are not smoking
时间窗: At 12 months post RT or CRT
Observed rates of patients who are not smoking at 12 months and corresponding 95% exact Clopper-Pearson confidence intervals will be estimated. Next, will perform a Fisher's exact test to determine whether the proportion of patients who are not smoking at 12 months post-RT/CRT in the bupropion hydrochloride group and the patient's choice group are different.
次要结局
- Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire(Up to 12 months)
- Proportion of patients who are not smoking at 6 months post RT or CRT(At 6 months)
- Proportion of patients who develop mucositis and mucositis-related pain evaluated by Common Terminology Criteria for Adverse Events(Up to 2 weeks post RT or CRT)
- Proportion of patients who experience smoking relapse among patients who quit smoking(At 12 months post RT or CRT)
- QOL as measured by MD Anderson Inventory(Up to 12 months)