Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- 7-day CO-verified Tobacco Abstinence
研究概览
简要总结
Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. With medical advances in cancer care yielding a growing constituency of cancer survivors, addressing nicotine dependence in this population is a priority. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Varenicline may be particularly effective for cancer patients given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in the extended therapy group versus the standard therapy group, and there will be no significant differences between groups in terms of severe side effects, and 3) Improved affect and reduced cognitive impairment will mediate the effect of extended therapy on quit rates.
详细描述
BACKGROUND
Prevalence of Smoking among Cancer Patients
The rate of smoking among individuals with cancer who are age 40 or under are substantially higher (38-40%) than rates of smoking in the comparable age group in the general population (~26%; Bellizzi et al., 2005; Coups & Ostroff, 2005). Studies with patients that have traditional tobacco-related cancers show extremely high rates of smoking; upwards of 50% of head and neck (Duffy et al., 2008) and lung (Cooley et al., 2009) cancer patients report current smoking. However, high rates of smoking are not unique to such traditional tobacco-related disease sites. Significant rates of current smoking have been reported among testicular (19%; Shinn et al., 2007), prostate (16-17%; Gong et al., 2008; Pantarotto et al., 2007), cervical (21%; Beesley et al., 2008), breast (19%; Li et al., 2009), bladder (18%; Blanchard et al., 2008), esophageal (39%; Sundelof et al., 2008), colorectal (22%; Vincenzi et al., 2009), and lymphoma (19%; Geyer et al., 2010) cancer patients. Overall, about one-third to one-half of cancer patients who were smokers prior to their diagnosis continue to smoke following diagnosis (Gritz et al., 2006).
Adverse Health Consequences of Smoking among Individuals with Cancer
Continued smoking by cancer patients has been associated with diminished QOL, reduced survival probability and duration, and increased risk for disease recurrence and a second primary tumor (Gritz et al., 2006; 2007). Continued smoking by cancer patients is associated with greater treatment side effects or diminished QOL among head and neck (Duffy et al., 2007; Zevallos et al., 2009), lung (Daniel et al., 2009), prostate (Ku et al., 2009), and a heterogeneous group of (Schnoll et al., 2010a) cancer patients. A recent meta-analysis of studies with lung cancer patients found that continued smoking was associated with an increased risk of death, recurrence, and a second primary tumor (Parsons et al., 2010). Likewise, studies with head and neck cancer patients have reported that patients who continue to smoke following their diagnosis have a lower survival rate and an increased risk for a recurrence and a second primary tumor (Browman et al., 2002; Hilgert et al., 2009; Fortin et al., 2009; Leon et al., 2009). Continued smoking has also been associated with reduced survival among breast (Aksoy et al., 2007), lymphoma (Geyer et al., 2010), esophageal (Sundelof et al., 2008), prostate (Gong et al., 2008), cervical (Coker et al., 2009), and bladder (Aveyard et al., 2002) cancer patients and with an increased risk of recurrence or a second primary tumor among bladder (Fleshner et al., 1999), breast (Li et al., 2009), lymphoma (Moser et al., 2006), and colorectal (Jacobson et al., 1994) cancer patients. Continued smoking may worsen prognosis by reducing the effectiveness of chemotherapy (Duarte et al., 2008; van der Bol et al., 2007; Vincenzi et al., 2009; Hotta et al., 2008) and radiotherapy (Browman et al., 1993).
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
- Double (Participant, Investigator)
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
- •18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average, for the last 6 months.
- •Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
- •Karnofsky Score of >50 or ECOG Performance Status score of <2 within 6 months of enrollment.
- •Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- •Residing in the geographic area for at least 12 months.
- •Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
- •Able to communicate fluently in English.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
排除标准
- •Smoking Behavior
- •Current enrollment or plans to enroll in another smoking cessation program in the next 12 months.
- •Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
- •Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 12 months.
- •Note: Once participants are found eligible for the study, they are told they should refrain from using any nicotine replacement therapy (NRT) for the duration of the study. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
- •Alcohol/Drug Exclusion Criteria
- •Diagnosis of substance abuse or dependence that has been unstable in the past year.
- •Positive urine drug screen (for cocaine, opioids, or methamphetamines) at the Intake Session (unless taking opiate for pain management).
- •Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
- •Current alcohol consumption that exceeds 25 standard alcoholic drinks/week.
- •Medication Exclusion Criteria
- •Current use or recent discontinuation (within last 14 days) of the following medications:
- •Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)
- •a. Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
- •Anti-psychotic medications.
- •Bipolar Disorder medications.
- •Medical Exclusion Criteria
- •Women who are pregnant, planning a pregnancy within the next 12 months, or lactating.
- •History of epilepsy or seizure disorder (history of seizure requires Study Physician approval).
- •History of kidney disease, including transplant.
- •Uncontrolled hypertension (SBP >160 or DBP >100).
- •a. Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on medication unless the study physician grants approval.
- •History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval).
- •Abnormal ECG (unless approved by Study Physician).
- •Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported suicide attempt.
- •Current or past diagnosis of psychotic or bipolar disorder, as determined by self-report & MINI.
- •Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
- •Previous allergic reaction to varenicline.
- •General Exclusion Criteria
- •Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- •Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
研究组 & 干预措施
Standard Varenicline Treatment
12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Days 85-168: Placebo - 1.0mg twice daily orally
干预措施: Varenicline (Drug)
Standard Varenicline Treatment
12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Days 85-168: Placebo - 1.0mg twice daily orally
干预措施: Placebo (Drug)
Standard Varenicline Treatment
12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Days 85-168: Placebo - 1.0mg twice daily orally
干预措施: Smoking Cessation Counseling (Behavioral)
Extended Varenicline Treatment
24 weeks of active varenicline + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally
干预措施: Varenicline (Drug)
Extended Varenicline Treatment
24 weeks of active varenicline + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally
干预措施: Smoking Cessation Counseling (Behavioral)
结局指标
主要结局
7-day CO-verified Tobacco Abstinence
时间窗: Weeks 24 & 52
Number of Participants with Verified 7 Day Tobacco Abstinence.
次要结局
- Quality of Life at Week 24 and 52(Weeks 24 & 52)