Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies

Conditions:Lung Cancer, Cancer, Cancer, Cancer, Smoking Cessation
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:July 2014
End Date:December 31, 2018
Contact:Kris Damron

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The purpose of this study is to find an optimal smoking cessation strategy in patients
undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky
by delivering high quality smoking cessation to all enrolled patients. This study will also
examine the feasibility of routinely implementing an array of smoking cessation strategies
for this patient population.

Subjects enrolled in the study will be placed in one of twelve treatment arms. Subjects in
each of the twelve treatment regimens will receive either varenicline or bupropion or
long-acting nicotine replacement therapy, with or without use of supplemental nicotine
replacement therapy, and in combination with either standard of care smoking cessation
counseling or high intensity/motivational smoking cessation counseling.

Inclusion Criteria:

- Patients must be ≥ 18 years of age.

- Patient with newly diagnosed or recurrent, histologic diagnosis of any of the
following tobacco related malignancies:

1. Lung or Bronchus cancer or Head & Neck, cancers (all sites).

2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix,
Vulvar, Vaginal

3. Carcinoma in situ undergoing definitive surgical resection or treatment (ex:

radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except
gynecologic patients undergoing ablative or local excisional therapies [laser
ablation,cervical conization, LEEP].

- Having smoked at least 1 cigarette within 4 weeks of study enrollment.

- Having at least a 10-pack year history of cigarette smoking.

- Having smoked at least one cigarette within 1 month of cancer diagnosis.

- Life expectancy is greater than 1 year.

- Patient has an AUDIT score of < 10.

- Therapy planned is of curative intent.

- Patients 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: Patient response of "Yes" to any question except question

- Hospitalized for psychiatric illness within the past two years.

- History of Bipolar disorder.

- Currently taking Bupropion for depression.

- Patient has taken monoamine oxidase inhibitors (MAOI) in the past two 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 enrollment and
agree to use method of contraception during and for 30 days following last cessation
drug dose.

- Patients within three months of a myocardial infarction.

- Patients with unstable angina or serious arrhythmia.

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

- Patient taking varenicline or bupropion within one month of study enrollment.

- Participation in any other investigational drug study within 4 weeks of study

- Currently enrolled in other professional tobacco cessation therapeutic intervention.

- Enrollment in a concurrent cancer therapeutic trial will require prior review and
approval by the study site PI to determine that there are no drug interactions
We found this trial at
Louisville, Kentucky 40202
Phone: 502-217-5229
Louisville, KY
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Ashland, Kentucky 41101
Phone: 606-408-1636
Ashland, KY
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Elizabethtown, Kentucky 42701
Phone: 270-234-3250
Elizabethtown, KY
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Hazard, Kentucky 41701
Phone: 606-487-7907
Hazard, KY
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Huntington, West Virginia 25702
Phone: 304-526-1807
Huntington, WV
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Lexington, Kentucky
Principal Investigator: Joseph Valentino, MD
Lexington, KY
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Morehead, Kentucky 40351
Phone: 606-783-6476
Morehead, KY
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Owensboro, Kentucky 42303
Phone: 270-691-8094
Owensboro, KY
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