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Treatment of Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery: A Randomized Trial of Varenicline (Chantix)

18 Years
Open (Enrolling)
Breast Cancer, Tobacco Dependence

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Trial Information

Treatment of Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery: A Randomized Trial of Varenicline (Chantix)

Inclusion Criteria:

- MSK patients recently diagnosed with breast cancer as per EMR or clinicians judgment
with treatment plan to include mastectomy and/or breast reconstruction;

- Self-reported average of 10 cigarettes daily during the previous year AND at least 1
pack of cigarettes smoked within the last 7 days.

- Breast surgery scheduled at MSKCC > 14 days from enrollment;

- Advised to quit smoking and willing to receive smoking cessation counseling and

Exclusion Criteria:

- Patients less than 18 years of age because the safety and efficacy of varenicline
have not yet been tested in children;

- Evidence of any known or suspected medical contraindications for use of varenicline
(e.g., recent (within past two months) cardiovascular instability (including
myocardial infarction or unstable angina; uncontrolled hypertension, significant
neurological sequelae of cerebrovascular disease, or severe congestive heart failure
(New York Heart Association class III or IV), severe chronic obstructive pulmonary
disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe
renal impairment.

- Self-reported use of other tobacco products (pipe, cigar, smokeless tobacco) or
marijuana in last 30 days;

- Self-reported evidence of significant psychiatric history (e.g., schizophrenia,
unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in
the investigators' judgment, to preclude participation in the clinical trial;

- Self-reported evidence of recent substance abuse or heavy alcohol use (> 14 drinks
weekly) in the last 6 months;

- Self-reported evidence of recent (in the past 30 days) or planned use of nicotine
replacement therapy (NRT) or other FDA approved cessation pharmacotherapy

- Pre-menopausal women who are pregnant as per EMR

- Women who are breast-feeding as per self-report.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

of varenicline and standard smoking cessation counseling to placebo and smoking cessation counseling with regard to tobacco cessation outcomes (point abstinence, continuous abstinence) in tobacco-dependent breast cancer patients scheduled for mastectomy and/or breast reconstruction surgery.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jamie Ostroff, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • Tobacco Dependence
  • Self-reported cigarettes smokers
  • Smoking Cessation
  • 11-136
  • mastectomy and breast reconstruction
  • Breast Neoplasms
  • Tobacco Use Disorder



Memorial Sloan-Kettering Cancer Center New York, New York  10021