Strategies to Promote Smoking Cessation in Patients with Tobacco Related Malignancies

Status: Closed to Accrual

Description

This randomized pilot clinical trial studies how well different strategies work to promote smoking cessation in patients with tobacco related malignancies. Combining different smoking cessation strategies, such as counseling, drug therapy, and as needed nicotine replacement therapy, may help patients with cancer quit smoking.

Eligibility Criteria

Inclusion Criteria

  • Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies: * Lung or bronchus cancer or head & neck, cancers (all sites) * Esophagus, stomach, pancreas, kidney, urinary bladder, colon, rectum, cervix, vulvar, vaginal * 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 Alcohol Use & Dependence (AUDIT) score of < 10
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • 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
  • Columbia Suicide Severity Rating Scale (C-SRSS) baseline/screening: * Patient response of “Yes” to any question in column two (past 6 months and past 10 years), except question 1 * Patient response of “Yes” to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation
  • Hospitalized for psychiatric illness within the past two years
  • History of bipolar disorder
  • Currently taking bupropion (bupropion hydrochloride) 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 an effective method to avoid pregnancy 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 enrollment
  • 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 principal investigator (PI) to determine that there are no drug interactions concerns

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To identify an efficacious, implementable cessation strategy for patients with tobacco related malignancies.

II. To assess the feasibility of routinely implementing an array of smoking cessation strategies for this population.

III. To deliver high quality smoking cessation to all subjects.

OUTLINE: Participants are randomized to 1 of 12 arms.

ARM I: Participants receive high-intensity counseling via telephone over 5-60 minutes for 8 sessions over 8 weeks and then an additional 3 sessions over 4 months; wear long-acting nicotine replacement therapy (NRT) patches once daily (QD) on weeks 1-8, weeks 1-10, or for up to 6 months at the discretion of the treating physician; and receive as needed (PRN) NRT gum or lozenges orally (PO) up to once per hour for up to 6 months at the discretion of the treating physician.

ARM II: Participants receive high-intensity counseling as in Arm I; receive bupropion hydrochloride PO QD for 3 days and then twice daily (BID) for a total of 7-12 weeks; and receive PRN NRT gum or lozenges as in Arm I.

ARM III: Participants receive high-intensity counseling as in Arm I; receive varenicline PO QD on days 1-3 and then BID for a total of 12 weeks; and receive PRN NRT gum or lozenges as in Arm I. Patients who are unable to quit abruptly may receive varenicline for up to 24 weeks.

ARM IV: Participants receive high-intensity counseling as in Arm I; wear long-acting NRT patches as in Arm I; and do not receive PRN NRT.

ARM V: Participants receive high-intensity counseling as in Arm I; receive bupropion hydrochloride as in Arm II; and do not receive PRN NRT.

ARM VI: Participants receive high-intensity counseling as in Arm I; receive varenicline as in Arm III; and do not receive PRN NRT.

ARM VII: Participants receive low-intensity counseling via telephone over 10-20 minutes once within 5 days of enrollment; wear long-acting NRT patches as in Arm I; and receive PRN NRT gum or lozenges as in Arm I.

ARM VIII: Participants receive low-intensity counseling as in Arm VII; receive bupropion hydrochloride as in Arm II; and receive PRN NRT gum or lozenges as in Arm I.

ARM IX: Participants receive low-intensity counseling as in Arm VII; receive varenicline as in Arm III; and receive PRN NRT gum or lozenges as in Arm I.

ARM X: Participants receive low-intensity counseling as in Arm VII; wear long-acting NRT patches as in Arm I; and do not receive PRN NRT.

ARM XI: Participants receive low-intensity counseling as in Arm VII; receive bupropion hydrochloride as in Arm II; and do not receive PRN NRT.

ARM XII: Participants receive low-intensity counseling as in Arm VII; receive varenicline as in Arm III; and do not receive PRN NRT.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
University of Kentucky / Markey Cancer Center

Principal Investigator
Joseph Valentino

Trial IDs

Primary ID MCC-13-MULTI-13-KCTN-1301
Secondary IDs NCI-2014-00939, NCI-2014-00879
Clinicaltrials.gov ID NCT02048917