Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 10
- 主要终点
- Cigarette use
研究概览
简要总结
The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.
详细描述
Subjects enrolled in the study will be placed in one of twelve treatment arms. Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 be ≥ 18 years of age.
- •Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
- •Lung or Bronchus cancer or Head & Neck, cancers (all sites).
- •Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
- •Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation,cervical conization, LEEP].
- •Having smoked at least 1 cigarette within 4 weeks of study enrollment.
- •Having at least a 10-pack year history of cigarette smoking.
- •Having smoked at least one cigarette within 1 month of cancer diagnosis.
- •Life expectancy is greater than 1 year.
- •Patient has an AUDIT score of <
- •Patient has ECOG Performance Status of <=
- •Patients must have the ability to understand and the willingness to provide signed written informed consent document.
排除标准
- •Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
- •History of suicide attempt or preparation for attempt within the past 10 years.
- •C-SRSS Baseline/Screening:
- •Patient response of "Yes" to any question except question
- •Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
- •Hospitalized for psychiatric illness within the past two years.
- •History of Bipolar disorder.
- •Currently taking Bupropion for depression.
- •Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
- •History of eating disorder such as anorexia or bulimia.
- •Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
- •History of epilepsy or seizure disorder.
- •Active severe kidney or liver disease.
- •Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
- •Patients within three months of a myocardial infarction.
- •Patients with unstable angina or serious arrhythmia.
- •Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
- •Patient taking varenicline or bupropion within one month of study enrollment.
- •Participation in any other investigational drug study within 4 weeks of study enrollment.
- •Currently enrolled in other professional tobacco cessation therapeutic intervention.
- •Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.
研究组 & 干预措施
High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
干预措施: High Intensity Counseling + bupropion (Drug)
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
干预措施: High Intensity Counseling + Long Acting NRT + PRN NRT (Drug)
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
干预措施: High Intensity Counseling + bupropion + PRN NRT (Drug)
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
干预措施: High Intensity Counseling + varenicline + PRN NRT (Drug)
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
干预措施: High Intensity Counseling + Long Acting NRT (Drug)
High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
干预措施: High Intensity Counseling + varenicline (Drug)
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
干预措施: Low Intensity Counseling + Long Acting NRT + PRN NRT (Drug)
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
干预措施: Low Intensity Counseling + bupropion + PRN NRT (Drug)
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
干预措施: Low Intensity Counseling + varenicline + PRN NRT (Drug)
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
干预措施: Low Intensity Counseling + Long Acting NRT (Drug)
Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
干预措施: Low Intensity Counseling + bupropion (Drug)
Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline
干预措施: Low Intensity Counseling + varenicline (Drug)
结局指标
主要结局
Cigarette use
时间窗: 8 weeks
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
次要结局
未报告次要终点
研究者
Joseph Valentino
Study Chair
University of Kentucky