Improving radiotherapy outcomes in head and neck cancer patients: A preliminary comparison of smoking cessation intervention ‘Varenicline plus support’ with ‘treatment as usual’

Dr Benjamin Britton0 个研究点目标入组 40 人开始时间: 2014年8月15日最近更新: 2020年1月13日

试验速览

暂无简介。

•Self-report smoking at least 5 cigarettes per day (on average in the preceding 3 months)
•- Diagnosed with Head and Neck Cancer (including skin)
•- Scheduled to undergo radiotherapy (definitive or adjuvant) for head and neck cancer (curative intent)
•- ECOG Performance Status score of <2 within 6 months of enrolment.
•- Able to use Varenicline safely (based on medical, physical and psychiatric evaluation)
•- Residing in the geographic area for at least 12 months.
•- Able to communicate fluently in English and capable of giving written informed consent.

•- Regular (daily) use of chewing tobacco, snuff/ snus, cigars, cigarillos, or pipes.
•- Current use or recent discontinuation (<6 months) of Buproprion cannot have been used in the preceding 6 months.
•- Women who are pregnant, planning a pregnancy within the next 12 months, or lactating.
•- History of epilepsy or seizure disorder.
•- History of kidney or liver disease, including transplant.
•- Uncontrolled hypertension (SBP >160 or DBP >100).
•- History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia
•- Current acute suicidal ideation or self-reported suicide attempt in the last 12 months.
•- Current diagnosis of unstable/ untreated major depression, bipolar disorder or psychotic disorder as determined by self-report (eligible if stable and compliant with treatment for >30 days).
•- Previous allergic reaction to Varenicline.
•Please note, that once patients are deemed to be eligible for the trial they will be required to refrain from starting non-study smoking cessation treatments (including, but not limited to, Nicotine Replacement Therapy, Buprenorphine, Psychological Intervention, Counselling). Patients who have already commenced NRT are eligible to participate.

发起方

Dr Benjamin Britton