Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)
NCT01532232
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title | Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix) | |||
Official Title | Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix) | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: saliva samples | |||
Sampling Method | Probability Sample | |||
Study Population | MSK breast clinic | |||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 7 | |||
Original Estimated Enrollment | 100 | |||
Actual Study Completion Date | October 2014 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01532232 | |||
Other Study ID Numbers | 11-136 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor | Memorial Sloan Kettering Cancer Center | |||
Collaborators | Pfizer | |||
Investigators |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | December 2015 |