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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Tobacco Dependence

Intervention: placebo (Drug); varenicline (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Jamie Ostroff, PhD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

Official title: Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)

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

Primary outcome: effectiveness

Secondary outcome:

examine baseline factors that are associated with poor treatment response

tolerability of and adherence

rates of surgical complications

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: February 2012
Last updated: July 14, 2015

Page last updated: August 20, 2015

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