Overview

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

Status:
Terminated
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
Summary
Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
Pfizer
Treatments:
Varenicline
Criteria
Inclusion Criteria:

- MSK patients diagnosed with breast cancer or have a mass suspicious of breast cancer
at the time of enrollment, as per clinician judgment or EMR;

- Self-reported current cigarette smoker (defined as daily smoking in the past seven
days)

- Advised to quit smoking by their MSK physician and willing to receive smoking
cessation counseling and treatment; as per self report

- Fluent in English

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 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 recent use (in the past 30 days) or planned use of nicotine replacement
therapy (NRT) or other FDA approved cessation pharmacotherapy (bupropion);

- Pre-menopausal women who are pregnant as per EMR

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