Trial name or title

Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer

Methods

Allocation: randomised

Endpoint classification: efficacy study

Intervention model: single group assignment

Masking: open label

Primary purpose: treatment

Participants

Inclusion criteria:

• clinical diagnosis of lung cancer

Exclusion criteria:

• refusal of consent

• inability to provide exhaled carbon monoxide

• active psychiatric illness or substance misuse

• concurrent malignancies of another type other than non‐melanoma skin cancer

• unable to travel for sessions with smoking cessation counsellor, outpatient visits from outset, or both

• WHO performance status 4

• Life expectancy < 6 weeks

Interventions

Experimental: intensive quit smoking support
Support by a hospital smoking cessation specialist and pharmacotherapy as per local stop‐smoking and British Thoracic Society protocols

Active comparator: physician advice to quit
5 minutes of advice, reading from a script based on the 5 'A's approach to smoking cessation and offered pharmacotherapy

Outcomes

Primary outcome:

• median and 2‐year survival rates in confirmed smokers versus non‐smokers newly diagnosed with lung cancer (time frame: 24 months)

Secondary outcome:

• median survival and 2‐year survival rates by smoking status for early (stage I/II NSCLC) versus those with advanced (stage III/IV) NSCLC (time frame: 24 months)

• number of treatment complications in smokers versus non‐smokers (frequency surgical wound complications, radiotherapy‐induced pneumonitis and median total radiation (Gy) dose; frequency and duration of neutropenic sepses (time frame: 2 years)

• point prevalence of smoking at 0, 3, 6 12 and 24 months (time frame: 2 years)

• comparison of changes in health‐related quality of life (EQ5D) in smokers versus non‐smokers (time frame: 2 years)

• accrual and attendance rates of people with lung cancer attending a hospital smoking cessation service (time Frame: 2 years)

• estimate of cost per quality‐adjusted life year gained by smoking cessation advice in both quit strategies for smokers (time frame: 2 years)

Starting date

March 2010

Contact information

Rachel E Roberts, BSc

Telephone: +44 1554756567 ext 3569

Email: [email protected]

Notes

www.clinicaltrials.gov/ct2/show/NCT01192256

Trial name or title

Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

Methods

Allocation: randomised,
Intervention model: parallel assignment
Masking: open label

Participants

Inclusion criteria:

• AJCC stages 0, I, II and III lung, breast, prostate, colorectal, bladder, head and neck, and cervical cancers (all histologies)

• reports smoking any amount in the last 7 days

• scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received ≥ 1 of the following in the last 6 months: surgery, last 4 radiation treatment or last chemotherapy treatment

• ≥ 18 years

• KPS of 70‐100

• ability to understand and the willingness to sign a written informed consent document

• willing to consider quitting smoking

Exclusion criteria:

• unstable cardiac disease ‐ defined as congestive heart failure, unstable angina, serious arrhythmias, or myocardial infarction in the past month

• current use or planned use of varenicline (Chantix), Zyban, bupropion or any other nicotinic receptor agonist (participants that discontinue use of these type drugs within 7 days are eligible)

• current probable alcohol abuse as defined by > 5 drinks per day for men and 4 drinks per day for women and an Alcohol Use Disorders Identification Test (AUDIT) score > 8. If participant answers "no" to 5 drinks per day for men and 4 drinks per day for women the participant is eligible. AUDIT assessment does not need to be administered. If participant answers "yes" to 5 drinks per day for men and 4 drinks per day for women the AUDIT assessment must be administered. If AUDIT score is > 8, participant is not eligible

• use of illegal drugs or use of prescription medications for non‐medical reasons in the past month

• current use of chewing, dipping and pipe tobacco, or cigars

• participant does not have regular access to a telephone to receive Quitline calls lasting 15‐30 minutes

• history of allergic reactions attributed to compounds of similar chemical or biological composition to NRT

• active peptic ulcer disease

• uncontrolled intercurrent illness including, but not limited to, ongoing, psychiatric illness/social situations that would limit compliance with study requirements

• due to unknown risks and potential harm to the unborn foetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device, Depo‐Provera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel with or without a cervical cap or sponge. They encouraged the participant to discuss this issue further with your doctors if you have any questions

• if the participant was pregnant, should become pregnant or suspected to be pregnant prior to or while participating in this study, the participant should inform the study physician immediately. NRT has the potential for teratogenic or abortifacient effects and is classified as a FDA Pregnancy category D drug. The US 12 Clinical Practice Guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns with safety. Pregnant women enrolled in the study and randomised to the Quitline group intervention should participate in the Quitline intervention but not receive the NRT

• because there was an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NRT, breastfeeding women were excluded from the study

Interventions

Experimental: nicotine replacement patch
Participants received a letter from their physician advising them to quit smoking, and undergo a 15‐ to 30‐minute smoking‐cessation counselling session by a trained research staff
The participants were educated and motivated about the importance of quitting smoking, and cancer‐specific quitting issues. They were called by Quitline in 2‐3 days and received a fact sheet about benefits of smoking cessation for people with cancer
Participants received 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12‐week period
Participants also learn behavioural tips and coping skills
Control group: no Intervention:
Participants received a letter from their physician advising them to quit smoking, the importance of quitting smoking for people with cancer, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also received standard of care from their oncology and other treatment providers that may or may not include NRT

Outcomes

• Evaluate a smoking cessation intervention among people with cancer (time frame: 24 weeks)

• Evaluate a smoking cessation intervention among people with cancer who were scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received ≥ 1 of the following within the last 6 months surgery, last radiation treatment or last chemotherapy treatment in a community outpatient setting

Starting date

October 2011

Contact information

US, North Carolina W F Baptist Health Winston Salem, North Carolina, US, 27157

Notes

www.clinicaltrials.gov/ct2/show/NCT01434342

Trial name or title

Smoking Cessation Strategies in Community Cancer Programs for Lung and Head and Neck Cancer Patients

Methods

Allocation: randomised

Endpoint classification: efficacy study

Intervention model: parallel assignment

Masking: open label

Primary purpose: treatment

Participants

Inclusion criteria:

• participants must be ≥ 18 years of age

• participant with newly diagnosed or recurrent, histological diagnosis of lung cancer or head and neck cancer (categories: oral cavity, pharynx and larynx only)

• having smoked at least 1 cigarette within 4 weeks of study enrolment

• having at least a 10‐pack‐year history of cigarette smoking

• having smoked at least 1 cigarette within 1 month of cancer diagnosis

• life expectancy > 1 year

• participant had an AUDIT score of < 10

• therapy planned was of curative intent

• participants must have the ability to understand and the willingness to provide signed written informed consent document

Exclusion criteria:

• 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: participant response of "Yes" to any question except question 1

• hospitalised for psychiatric illness within the past 2 years

• history of bipolar disorder

• currently taking bupropion for depression

• participant has taken monoamine oxidase inhibitors in the past 2 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 enrolment and agree to use method of contraception during and for 30 days following last cessation drug dose

• participants within 3 months of a myocardial infarction

• participants with unstable angina or serious arrhythmia

• participants with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake

• participant taking varenicline or bupropion within 1 month of study enrolment

• participation in any other investigational drug study within 4 weeks of study enrolment

• currently enrolled in other professional tobacco cessation therapeutic intervention

• enrolment in a concurrent cancer therapeutic trial will require prior review and approval by the study site principal investigator to determine that there are no drug interactions concerns

Interventions

• High‐intensity counselling + long‐acting NRT + PRN NRT

• High‐intensity counselling + bupropion + PRN NRT

• High‐intensity counselling + varenicline + PRN NRT

• High‐intensity counselling + long‐acting NRT

• High‐intensity counselling + bupropion

• High‐intensity counselling + varenicline

• Low‐intensity counselling + long‐acting NRT + PRN NRT

• Low‐intensity counselling + bupropion + PRN NRT

• Low‐intensity counselling + varenicline + PRN NRT

• Low‐intensity counselling + long‐acting NRT

• Low‐intensity counselling + bupropion

• Low‐intensity counselling + varenicline

Outcomes

Cigarette use (time frame: 8 weeks)
7‐day point prevalence of cigarette use confirmed with carbon monoxide testing at 8 weeks

Starting date

July 2014

Contact information

Kris Damron

Telephone: 859‐323‐1109

Email: [email protected]

Notes

www.clinicaltrials.gov/ct2/show/NCT02048917