TerminatedPhase 4ACTRN12614000876695

Improving radiotherapy outcomes with smoking cessation: Feasibility trial in head and neck cancer patients

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

Sponsor

Dr Benjamin Britton

Enrollment

40 participants

Start Date

Oct 3, 2014

Study Type

Interventional

Conditions

Radiotherapy Smoking

Summary

This study will determine whether a smoking cessation program may improve radiotherapy outcomes in patients with head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, a smoker and have been diagnosed with head and neck cancer (including skin cancer), for which you are scheduled to undergo radiotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will participate in a multicomponent smoking cessation program which includes an initial three-month course of oral tablets (Varenicline), with the possibility of an additional three-month course to maintain abstinence, as well as 10 behaviour change sessions with a psychologist. Participants in the other group will receive standard NSW Health tobacco assessment and smoking cessation advice. Both groups will receive their standard radiotherapy treatment. Participants will be followed-up for up to 6 months, in order to determine compliance to and side effects of the smoking cessation program, behaviour change and tumour response to radiotherapy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

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.

Exclusion Criteria11

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.

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Interventions

Multicomponent Smoking Cessation Intervention (Varenicline + Behaviour Change Counselling; “Stop Smoking Support”) Varenicline will be administered orally via tablets in accordance with approved labelling. Dose titration will be: 0.5 mg/d for days 1 to 3; 1 mg/d for days 4 to 7; and 2 mg/d (the target dose) from days 8 to 84. In accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (2009), patients who successfully complete the initial 3-month course will be offered an additional 3-month course (2mg/d) to assist with maintaining abstinence. Varenicline will be provided at no cost to participants. The initial course of Varenicline will be distributed at treatment planning. Patients who successfully complete the initial 3 month course will receive a further 84 day supply of Varenicline during their appointment with the radiation oncologist (RO) following RT completion. Medication adherence will be evaluated via self-report and pill count. Medication compliance will be explicitly discussed by the RO and psychologist as part of the Behaviour Change Counselling Intervention. The psychologist will also administer an established medication adherence questionnaire at each appointment. At each follow-up assessment, participants will be asked to return the blister packs administered at the preceding timepoint. Any missed medication will be retained by the research staff and counted. Any outstanding medication will be returned to the participant along with the next instalment of medication. At the time of treatment planning (simulation), RO's will offer brief medical advice to quit. This brief intervention is designed to supplement Varenicline administration to assist patients to stop smoking. Brief advice will also be integrated into routine consultations. Intervention participants will also receive up to 10 sessions of manual-based motivational interviewing and cognitive behaviour therapy (CBT) delivered by a psychologist. Sessions will include 2 x ‘pre-quit’ and 1 x ‘quit day’ sessions (of up to one hour) and 7 x ‘relapse prevention’ sessions (of up to 30min). Sessions will be weekly for the first four weeks and approximately fortnightly-monthly thereafter (as needed and according to patient preference). To position smoking cessation as central to radiotherapy, sessions will be offered in the radiotherapy outpatient department. Telephone sessions will be offered as an alternative, according to patient preference. Counselling is included given its efficacy at helping smokers quit (Fiore et al., 2008).