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

Phase 4

• Conditions: Smoking; Head and neck cancer; Radiotherapy; Cancer - Head and neck; Mental Health - Addiction

• Registration Number: ACTRN12614000876695
• Lead Sponsor: Dr Benjamin Britton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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 Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified